Country: United States
Language: English
Source: NLM (National Library of Medicine)
WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4)
Medline Industries, LP
TOPICAL
OTC DRUG
Skin protectant - temporarily protects and helps releve - minor cuts - scrapes - burns - chapped or cracked skin and lips
OTC monograph final
MEDLINE- PETROLATUM OINTMENT MEDLINE INDUSTRIES, LP _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._ ---------- 186 CURAD VITAMIN A&D OINTMENT _ACTIVE INGREDIENT (IN EACH GRAM)_ White petrolatum 93.4% w/w, USP _PURPOSE_ Skin protectant _USES_ temporarily protects and helps releve minor cuts scrapes burns chapped or cracked skin and lips _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 if symptoms last for more 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_ apply as needed _OTHER INFORMATION_ store at controlled room temperature 68-77°F (20-25°C) use only if package is intact _INACTIVE INGREDIENTS_ lavender oil, light mineral oil, vitamin A palmitate, vitamin D MANUFACTURING INFORMATION Manufactured for: Medline Industries, LP Three Lakes Drive, Northfield, IL 60093 USA www.curad.com 1-800-633-5463 Made in India REF: CUR003501 V2 RB23GZP 53329-186-14 PACKAGE LABEL MEDLINE Medline Industries, LP petrolatum ointment PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:53329-186 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4) WHITE PETROLATUM 934 mg in 1 g INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH LIGHT MINERAL OIL (UNII: N6K5787QVP) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) VITAMIN D (UNII: 9VU1KI44GP) LAVENDER OIL (UNII: ZBP1YXW0H8) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:53329-186- 16 5 g in 1 PACKET; Type 0: Not a Combination Product 04/01/2023 2 NDC:53329-186- 96 144 in 1 BOX 04/01/2023 2 Read the complete document