Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)
ASTONEA LABS PRIVATE LIMITED
TOPICAL
OTC DRUG
Skin Protectant - temporarily protects minor cuts, scrapes, burns and sunburn - temporarily protects and helps relieve chapped or cracked skin - helps protect from drying effect of wind and cold weather - helps treat and prevent diaper rash - help seal out wetness - condition worsens - symptoms last for more than 7 days or clean up and occur again in a few days - deep or puncture wounds - animal bites - serious burns
OTC monograph final
PETROLATUM JELLY- PETROLATUM JELLY ASTONEA LABS PRIVATE LIMITED _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._ ---------- ASTONEA 99.9% _ACTIVE INGREDIENT_ White Petrolatum (99.9% w/w) _PURPOSE_ Skin Protectant _USES_ temporarily protects minor cuts, scrapes, burns and sunburn temporarily protects and helps relieve chapped or cracked skin helps protect from drying effect of wind and cold weather helps treat and prevent diaper rash help seal out wetness _WARNINGS_ FOR EXTERNAL USE ONLY WHEN USING THIS PRODUCT do not get into the eyes STOP USE AND ASK A DOCTOR IF condition worsens symptoms last for more than 7 days or clean 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_ apply as needed _INACTIVE INGREDIENT_ Fragrance PACKAGE LABEL ASTONEA LABS PRIVATE LIMITED PETROLATUM JELLY petrolatum jelly PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:77338-101 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 99.9 g in 100 g INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH WATER (UNII: 059QF0KO0R) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:77338-101- 03 226 g in 1 JAR; Type 0: Not a Combination Product 01/01/2023 2 NDC:77338-101- 05 368 g in 1 JAR; Type 0: Not a Combination Product 01/01/2023 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC monograph final part347 10/11/2016 LABELER - ASTONEA LABS PRIVATE LIMITED (878533295) Revised: 1/2023 Lire le document complet