Yellow Soft Paraffin

(USAN, rINN)
Synonyms: Keltavaseliini; Minkštasis geltonas parafinas; Paraff. Moll. Flav.; Paraffinum Molle Flavum; Petrolatum; Petroleum Jelly; Sárga vazelin; Vaselin, gult; Vaselina Amarela; Vaselina amarilla; Vaselina filante amarilla; Vaseline jaune; Vaselinum flavum; Vazelína žlutá; Wazelina z ółta; Yellow Petrolatum; Yellow Petroleum Jelly.
Cyrillic synonym: Жёлтый Вазелин.

💊 Chemical information

CAS — 8009-03-8.

Pharmacopoeias.

In Chin., Eur., Int., Jpn, and US. Many pharmacopoeias use the title Vaselinum Flavum; in some countries the name ‘Vaseline’ is a trade-mark.

Ph. Eur. 6.2

(Paraffin, Yellow Soft). A purified mixture of semisolid hydrocarbons obtained from petroleum. A yellow, translucent, unctuous mass, slightly fluorescent in daylight when melted. It has a drop point of 40° to 60°. Practically insoluble in water, in alcohol, and in glycerol; slightly soluble in dichloromethane. Protect from light.

USP 31

(Petrolatum). A purified mixture of semi-solid hydrocarbons obtained from petroleum. It may contain a suitable stabiliser. It is an unctuous yellowish to light amber mass, having not more than a slight fluorescence even after being melted. It is transparent in thin layers. It is free or practically free from odour. M.p. 38° to 60°. Insoluble in water; practically insoluble in cold or hot alcohol and in cold dehydrated alcohol; freely soluble in benzene, in carbon disulfide, in chloroform, and in turpentine oil; soluble in ether, in petroleum spirit, and in most fixed and volatile oils.

💊 Adverse Effects

Adverse effects of soft paraffin are rare when used in topical preparations, but sensitivity reactions and acne have been reported after topical use. Granulomatous reactions after absorption or injection and lipoid pneumonia after aspiration have occurred.

Fire risk.

Burns to the scalp, face, and hands have been reported1 in 5 patients who accidentally ignited their hair after the application of paraffin-based hair grease. Four patients suffered inhalation injury, 2 of whom required intubation. The death of a patient who, while smoking, ignited bandages covering a paraffin-based ointment for psoriasis,2 prompted the BNF to recommend that patients should be told not to smoke and to keep away from flames when using paraffin-based emollients.
1. Bascom R, et al. Inhalation injury related to use of petrolatumbased hair grease. J Burn Care Rehabil 1984; 5: 327–30
2. National Patient Safety Agency. Skin treatment fire risk. Patient Safety Bulletin 2007 (Jan.)
4. Available at: http:// www.npsa.nhs.uk/EasySiteWeb/GatewayLink.aspx?alId=6341 (accessed 29/08/08)

Hypersensitivity.

The allergenicity of soft paraffin products has been investigated.1-4 Considering their widespread use there are very few reports of sensitivity;4 of nearly 80 000 patients patch tested with white soft paraffin, only 29 showed a positive reaction. White soft paraffin is generally less sensitising than yellow soft paraffin, although allergenicity differs from product to product. The allergenic components are probably polycyclic aromatic hydrocarbons present as impurities and quantities found in a particular paraffin depend on the source and purification method. Only the purest forms should be used in pharmaceuticals, cosmetics, and for patch testing, and highly purified white soft paraffin is preferred to yellow soft paraffin.
1. Dooms-Goossens A, Degreef H. Contact allergy to petrolatums (I). Sensitising capacity of different brands of yellow and white petrolatums. Contact Dermatitis 1983; 9: 175–85
2. Dooms-Goossens A, Degreef H. Contact allergy to petrolatums (II). Attempts to identify the nature of the allergens. Contact Dermatitis 1983; 9: 247–56
3. Dooms-Goossens A, Dooms M. Contact allergy to petrolatums (III). Allergenicity prediction and pharmacopoeial requirements. Contact Dermatitis 1983; 9: 352–9
4. Schnuch A, et al. White petrolatum (Ph. Eur.) is virtually nonsensitizing: analysis of IVDK data on 80 000 patients tested between 1992 and 2004 and short discussion of identification and designation of allergens. Contact Dermatitis 2006; 54: 338–43.

Lipoid pneumonia.

Various uses of soft paraffin have been associated with lipoid pneumonia, including topical facial use to treat psoriasis,1 long-term intranasal application for a dry nose,2and use as a lubricant during nasogastric intubation.3
1. Cohen MA, et al. Exogenous lipoid pneumonia caused by facial application of petrolatum. J Am Acad Dermatol 2003; 49: 1128–30
2. Brown AC, et al. Exogenous lipoid pneumonia due to nasal application of petroleum jelly. Chest 1994; 105: 968–9
3. Bernabeu Mora R, et al. Neumonía lipoidea aguda debiba a la aspiratión accidental de vaselina utilizada en un sondaje nasogástrico. Arch Bronconeumol 2000; 36: 485–7.

💊 Uses and Administration

Soft paraffin is used as an ointment basis and as an emollient in the management of skin disorders. It is not readily absorbed by the skin. Sterile dressings containing soft paraffin are used for wound dressing and as a packing material. Soft paraffin is also included in ointments used as ophthalmic lubricants in the management of dry eye. Application of soft paraffin has been used for the eradication of pubic lice from the eyelashes. It has been used as a contact medium to reduce pain during extracorporeal shock wave lithotripsy. Soft paraffin is also used in food manufacturing.

💊 Preparations

BP 2008: Cetomacrogol Emulsifying Ointment; Cetrimide Emulsifying Ointment; Emulsifying Ointment; Paraffin Ointment; Simple Eye Ointment; Simple Ointment; Wool Alcohols Ointment; USP 31: Bland Lubricating Ophthalmic Ointment; Hydrophilic Ointment; Hydrophilic Petrolatum; Petrolatum Gauze; White Ointment; Yellow Ointment.

Proprietary Preparations

Austral.: Jelonet; Uni Salve†; Unitulle†; Braz.: Vaselina; Canad.: Prevex; Vaseline; Fr.: Cuticerin; Jelonet; Tulle Gras; Vaselitulle; Ger.: Oleo Tull; Gr.: Vaseline Pur; Irl.: Dermamist; Ital.: Adaptic; Jelonet; Lomatuell H; Mex.: Formula Dermica; Lubrilin; Philipp.: Apollo; Rus.: Kliotex (Клиотекс); S.Afr.: Jelonet; Spain: Lacrilube; Turk.: Duratears; UK: Dermamist; Jelonet; Paratulle†; Vaseline; USA: Ocu-Lube. Multi-ingredient: Arg.: Alcon Lagrimas; Aqualane; Benzalcrem; Austral.: DermaVeen Moisturising; Dermeze; E45; Gold Cross Skin Basics Zinc Cream†; Lacri-Lube; Poly Visc; Austria: Tiroler Steinol; Belg.: Duratears; Lacrytube; Tulle Vaseline†; Canad.: A & D Ointment; Akwa Tears; Chapstick Medicated Lip Balm†; Duolube; Duratears†; Hydrophil; Hypotears; Moisturel; Optilube; Puralube†; Refresh Lacri-Lube; Tears Naturale PM; Chile: Chapstick Medicated; Durasolets; Duratears; Lacri-Lube; Pasta Lassar; Denm.: Ojensalve Neutral; Fin.: Lacri-Lube; Fr.: Cellosorb; Codexial Zinc; Dexeryl; Grassolind Neutral; Ictyane; Ictyane HD; Oilatum Cream†; Transulose; Ger.: Allergika†; Cellosorb; Coliquifilm; Sofra-Tull sine; VitaPOS; Gr.: Duratears; Vaseline Borique; Vaseline Oxyde Zinc; Hong Kong: Balneum; Duratears; Dyprotex†; Oilatum Cream; India: Cetraben; Irl.: Lacri-Lube; Oilatum Junior; Israel: Duratears; Kamil Blue; Lacrimol; Ital.: Lacrilube; Malaysia: Balneum; Duratears Naturale; Lacrilube†; Oilatum; Neth.: Duratears Z; Transulose; Norw.: Simplex; NZ: Lacrilube; Poly-Visc; Philipp.: Oilatum; Pol.: Amfobase; Diprobase; E45; Unibasis; Singapore: Balneum; Duratears; Lacrilube; Spain: Lubrifilm; Tears Lubricante†; Vaselina Boricada; Vaselina Mentolada†; Switz.: Coliquifilm; Thai.: Balneum†; Duratears; Oilatum Cream; Turk.: Cinkos; UK: 50:50; Cetraben Emollient; Diprobase; Emollin; Epaderm; Hewletts; Hydromol; Imuderm; Lacri-Lube; Lubri-Tears; Melrose; Oilatum Cream; Oilatum Junior; USA: Akwa Tears; Bodi Care Lotion; Bottom Better; Chapstick Medicated Lip Balm; Desitin Creamy; Diaper Guard; Dry Eyes; Duratears Naturale; Formulation R; Hemorid For Women; Hydrocerin; Hypotears; Lacri-Gel; Lacri-Lube; LubriFresh PM; LubriTears; Paladin; Puralube; Refresh PM; Stye; Tears Again; Tears Renewed; Venez.: Lacrimart†.
Published November 14, 2018.