Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)
Vi-Jon, LLC
TOPICAL
OTC DRUG
Skin Protectant - helps treat and prevent diaper rash - protects chafed skin due to diaper rash - helps seal out wetness - deep or puncture wounds - animal bites - serious burns - condition worsens - systems last longer than 7 days or clear up and occur again within a few days
OTC monograph final
WHITE PETROLATUM- WHITE PETROLATUM JELLY VI-JON, LLC _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._ ---------- BABY PETROLEUM JELLY 960.000/960AA ACTIVE INGREDIENT White Petrolatum, USP (100%) PURPOSE Skin Protectant USES helps treat and prevent diaper rash protects chafed skin due to diaper rash helps seal out wetness WARNINGS FOR EXTERNAL USE ONLY DO NOT USE ON deep or puncture wounds animal bites serious burns WHEN USING THIS PRODUCT do not get into eyes STOP USE AND ASK A DOCTOR IF condition worsens systems last longer than 7 days or clear up and occur again within a few days KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS change wet and soiled diapers promptly cleanse the diaper area, and allow to dry apply product liberally as often as necessary, with each diaper change, and especially at bedtime or anytime when exposure to wet diapers may be prolonged INACTIVE INGREDIENTS None PRINCIPAL DISPLAY PANEL 100% Pure Petroleum Jelly NET WT 2.5 OZ (71 g) WHITE PETROLATUM white petrolatum jelly PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:11344-960 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 1 g in 1 g Vi-Jon, LLC PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:11344-960- 18 71 g in 1 TUBE; Type 0: Not a Combination Product 07/15/2015 2 NDC:11344-960- 27 369 g in 1 TUBE; Type 0: Not a Combination Product 07/15/2015 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC monograph final part347 07/15/2015 LABELER - Vi-Jon, LLC (790752542) REGISTRANT - Vi-Jon, LLC (790752542) ESTABLISHMENT NAME ADDRESS ID/FEI BUSINESS OP Soma hati kamili