Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)
Universal Distribution Center LLC
TOPICAL
OTC DRUG
Purpose Skin Protectant Uses - For the temporary protection of minor cuts, scrapes, burns and sunburn. - Helps to temporarily protect chafed, chapped, cracked or windburned skin and lips.
OTC monograph final
UNIVERSAL COCOA BUTTER SCENT PETROLEUM- WHITE PETROLEUM JELLY UNIVERSAL DISTRIBUTION CENTER 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._ ---------- UNIVERSAL COCOA BUTTER SCENT PETROLEUM ACTIVE INGREDIENT White Petrolatum USP (99.9 %) PURPOSE Skin Protectant USES For the temporary protection of minor cuts, scrapes, burns and sunburn. Helps to temporarily protect chafed, chapped, cracked or windburned skin and lips. WARNINGS FOR EXTERNAL USE ONLY. DO NOT USE over deep or puncture wounds, infections or lacerations. Ask a doctor. WHEN USING THIS PRODUCT avoid contact with eyes. STOP USE AND ASK DOCTOR if condition worsens or does not improve within 7 days. KEEP OUT OF REACH OF CHILDREN if swallowed get medical help or contact a Poison Control Center right away. DIRECTIONS Apply product as liberally, as often as necessary. INACTIVE INGREDIENTS Fragrance PRINCIPAL DISPLAY PANEL Universal Cocoa Butter Scent Petroleum Jelly Net Wt. 8 OZ (226 g) UNIVERSAL COCOA BUTTER SCENT PETROLEUM white petroleum jelly PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:52000-119 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:52000-119- 01 170 g in 1 JAR; Type 0: Not a Combination Product 11/01/2019 2 NDC:52000-119- 02 226 g in 1 JAR; Type 0: Not a Combination Product 11/01/2019 3 NDC:52000-119- 03 368 g in 1 JAR; Type 0: Not a Combination Product 11/01/2019 4 NDC:52000-119- 04 510 g in 1 JAR; Type 0: Not a Combination Product 11/01/2019 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING Preberite celoten dokument