Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)
Ultra Seal Corporation
PETROLATUM
PETROLATUM 1 g in 1 g
TOPICAL
OTC DRUG
Purpose: Skin Protectant Temporarily protects minor cuts, scrapes, and burns. Temporarily protects and helps chapped or cracked skin and lips. Helps protect lips from drying effects fo wind and cold weather.
OTC monograph final
ADVANCED PETROLATUM- PETROLATUM OINTMENT ULTRA SEAL CORPORATION _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._ ---------- DRUG FACTS Active Ingredients White Petrolatum 100% Purpose: Skin Protectant Temporarily protects minor cuts, scrapes, and burns. Temporarily protects and helps chapped or cracked skin and lips. Helps protect lips from drying effects fo wind and cold weather. For external use only. Do not use in eyes, on puncture wounds, animal bites, or serious burns or for more than one week unless directed by a doctor.. Stop use and ask a doctor if condition worsens, persists, or recurs. Keep out of reach of children Directions: Apply as needed Inactive Ingredients: None ADVANCED PETROLATUM petrolatum ointment PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:42213-042 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 INACTIVE INGREDIENTS Ultra Seal Corporation INGREDIENT NAME STRENGTH MINERAL OIL (UNII: T5L8T28FGP) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:42213-042- 80 144 in 1 BOX 04/05/2011 1 NDC:42213-042- 05 5 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:42213-042- 28 28 g in 1 TUBE; Type 0: Not a Combination Product 04/05/2011 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC monograph final M016 04/05/2011 05/31/2023 LABELER - Ultra Seal Corporation (085752004) REGISTRANT - Ultra Seal Corporation (085752004) ESTABLISHMENT NAME ADDRESS ID/FEI BUSINESS OPERATIONS Ultra Seal Corporation 085752004 pack(42213-042) ESTABLISHMENT NAME ADDRESS ID/FEI BUSINESS OPERATIONS Ultra Seal Corporation 944090448 pack(42213-042) Revised: 12/2022 Baca dokumen lengkapnya