Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
White Petrolatum USP 100%
GERITREX LLC
TOPICAL
OTC DRUG
Skin Protectant - Temporarily protects minor: - cuts - scrapes - burns - Temporarily protects and helps chapped lips and cracked skin
OTC monograph final
WHITE PETROLATUM- WHITE PETROLATUM OINTMENT GERITREX 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._ ---------- WHITE PETROLATUM USP OINTMENT DRUG FACTS ACTIVE INGREDIENTS White Petrolatum USP 100% PURPOS E Skin Protectant US ES Temporarily protects minor: cuts scrapes burns Temporarily protects and helps chapped lips and cracked skin WARNINGS FOR EXTERNAL USE ONLY STOP USE AND ASK A DOCTOR IF: condition worsens symptoms last for more than 7 days or clear up and occur again within a few days WHEN USING THIS PRODUCT: AVOID CONTACT WITH EYES DON'T NOT USE ON: deep or puncture wounds animal bites serious burns In case of deep puncture wounds or severe burns, consult a physician. If irritation, swelling or pain persists, or infection occurs, discontinue use and consult a physician. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS Cleanse area with mild soap and water. Apply White Petrolatum liberally. OTHER INFORMATION Avoid excessive heat and humidity Store at 15-30°C (59-86°F) WHITE PETROLATUM white petrolatum ointment PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:5416 2-59 7 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 1 g in 1 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH ALPHA-TO CO PHERO L (UNII: H4N8 55PNZ1) 0 .0 0 1 g in 1 g PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:5416 2-59 7-28 28 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct 0 9 /27/20 18 2 NDC:5416 2-59 7-0 5 5 g in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct 0 7/31/20 15 MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE Lestu allt skjalið