Country: United States
Language: English
Source: NLM (National Library of Medicine)
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)
Lincoln Pharmaceuticals Ltd.
TOPICAL
OTC DRUG
Skin Protectant - helps treat and prevent diaper rash - helps seal out wetness - temporarily protects minor cuts, scrapes, burns - temporarily helps protect and relieve chapped and cracked skin or lips - helps prevent and protect from the drying effects of wind and cold weather - helps prevent and protect chafed skin in minor irritations associated with diaper rash - with each diaper change, especially at bedtime when exposure to wet diapers may be prolonged - conditions worsens - symptoms last more than 7 days or clear up and occur again in a few days - deep or puncture wounds - animal bites - serious burns
OTC monograph final
LINCOLN- WHITE PETROLATUM OINTMENT LINCOLN PHARMACEUTICALS LTD. _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they_ _comply with applicable regulations and policies. FDA has not evaluated whether this product complies._ ---------- _ACTIVE INGREDIENT_ White Petrolatum USP (76% w/w) _PURPOSE_ Skin Protectant _USES_ helps treat and prevent diaper rash helps seal out wetness temporarily protects minor cuts, scrapes, burns temporarily helps protect and relieve chapped and cracked skin or lips helps prevent and protect from the drying effects of wind and cold weather helps prevent and protect chafed skin in minor irritations associated with diaper rash with each diaper change, especially at bedtime when exposure to wet diapers may be prolonged _WARNINGS:_ FOR EXTERNAL USE ONLY WHEN USING THIS PRODUCT: do not get into eyes STOP USE AND ASK A DOCTOR IF conditions worsens symptoms last more than 7 days or clear up and occur again in a few days DO NOT USE ON deep or puncture wounds animal bites serious burns KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away _DIRECTIONS_ For Diaper Rash: change wet and soiled diaper promptly cleanse the diaper area allow to dry apply as needed OTHER INFORMATION store at room temperature 15° - 30 °C (59-86 F) avoid excessive heat and humidity _INACTIVE INGREDIENTS_ lanolin, lavender oil, light liquid paraffin, vitamin A, Vitamin D LINCOLN white petrolatum ointment PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 9 6 36 -30 45 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH PETRO LATUM (UNII: 4T6 H12BN9 U) (PETROLATUM - UNII:4T6 H12BN9 U) PETROLATUM 76 g in 10 0 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH LAVENDER O IL (UNII: ZBP1YXW0 H8 ) VITAMIN A (UNII: 8 1G40 H8 B0 T) Lincoln Pharmaceuticals Ltd. VITAMIN D (UNII: 9 VU1KI44GP) LANO LIN (UNII: 7EV6 5EAW6 H) LIGHT MINERAL O IL (UNII: N6 K57 Read the complete document