Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)
Davion, Inc.
PETROLATUM
PETROLATUM 100 g in 100 g
TOPICAL
OTC DRUG
Skin Protectant - temporarily protects minor, cuts, scrapes, and burns - temporarily protects and helps relieve chapped or cracked skin and lips - Helps protect from the drying effects of wind and cold weather
OTC monograph final
PETROLEUM JELLY- WHITE PETROLATUM JELLY DAVION, INC. _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 INGREDIENT WHITE PETROLATUM, USP (100%) PURPOSE Skin Protectant USES temporarily protects minor, cuts, scrapes, and burns temporarily protects and helps relieve chapped or cracked skin and lips Helps protect from the drying effects of wind and cold weather DIRECTIONS: apply as needed WARNINGS: FOR EXTERNAL USE ONLY. WHEN USING THIS PRODUCT do not get into eyes. SEE A DOCTOR IF if condition worsens or lasts more than 7 days. DO NOT USE ON deep or puncture wounds animal bites serious burns KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away. INACTIVE INGREDIENT PRINCIPAL LABEL DISPLAY PANEL NDC 42669-214-06 Perfect Purity Pure Petroleum Jelly GUARANTEED PURE 100% PURE NET WT. 6 OZ. (170 g) NDC 42669-214-13 Perfect Purity Petroleum Jelly Skin Protectant For minor cuts, scrapes and burns NET WT. 13 OZ. (369 g) PETROLEUM JELLY white petrolatum jelly Davion, Inc. PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:42669-214 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 100 g in 100 g PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:42669-214- 06 170 g in 1 JAR; Type 0: Not a Combination Product 01/10/2017 2 NDC:42669-214- 13 369 g in 1 JAR; Type 0: Not a Combination Product 01/10/2017 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC monograph final part347 01/10/2017 LABELER - Davion, Inc. (174542928) REGISTRANT - Davion, Inc. (174542928) Revised: 12/2022 Les hele dokumentet