Country: United States
Language: English
Source: NLM (National Library of Medicine)
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)
Anicare Pharmaceuticals Pvt. Ltd
TOPICAL
OTC DRUG
Purpose Skin Protectant Uses - temporarily protects minor; cuts, scrapes or burns. temporarily protects minor; cuts, scrapes or burns. - temporarily protects and helps relieve chapped or cracked skin. temporarily protects and helps relieve chapped or cracked skin. - helps protect from the drying effects of wind and cold weather. helps protect from the drying effects of wind and cold weather. Stop use and ask a doctor if - condition worsens - symptoms last more than 7 days or clear up and occur again within a few days. Do not use on - deep puncture wounds - animal bites - serious burns
OTC monograph final
HEALTH SMART CREAMY PETROLEUM- PETROLEUM JELLY ANICARE PHARMACEUTICALS PVT. 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._ ---------- HEALTH SMART CREAMY PETROLEUM JELLY ACTIVE INGREDIENT Petrolatum 30% PURPOS E Skin Protectant US ES temporarily protects minor; cuts, scrapes or burns. temporarily protects and helps relieve chapped or cracked skin. helps protect from the drying effects of wind and cold weather. WARNINGS FOR EXTERNAL USE ONLY. WHEN USING THIS PRODUCT do not get into eyes. STOP USE AND ASK A DOCTOR IF condition worsens symptoms last more than 7 days or clear up and occur again within a few days. DO NOT USE ON deep 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 apply as needed. INACTIVE INGREDIENTS water (aqua), carbopol 940, stearic acid, glyceryl monostearate, mineral oil, cetearyl alcohol, GE125 emulsifying agent, methylparaben, propylparaben, triethanolamine, tocopheryl acetate. PRINCIPAL DISPLAY PANEL HEALTH SMART CREAMY PETROLEUM JELLY NET WT. 4.5 OZ. (128G) HEALTH SMART CREAMY PETROLEUM petroleum jelly PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:470 46 -16 6 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 30 g in 10 0 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) CARBO MER HO MO PO LYMER TYPE C ( ALLYL PENTAERYTHRITO L CRO SSLINKED) (UNII: 4Q9 3RCW27E) STEARIC ACID (UNII: 4ELV7Z6 5AP) GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4) MINERAL O IL (UNII: T5L8 T28 FGP) Anicare Pharmaceuticals Pvt. Ltd CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S) METHYLPARABEN (UNII: A2I8 C7HI9 T) PRO PYLPARABEN (UNII: Z8 IX2SC1OH) TRO LAMINE (UNII Read the complete document