البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)
Shield Line LLC
TOPICAL
OTC DRUG
Skin Protectant - provides relief to dry skin and lips - offers soothing protection for minor burns - provides protection for skin from wind burn and chapping - redness or swelling develops
OTC monograph final
PETROLATUM JELLY WITH COCOA BUTTER- PETROLATUM JELLY SHIELD LINE 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._ ---------- DRUG FACTS White Petrolatum USP 99.9% Skin Protectant USES provides relief to dry skin and lips offers soothing protection for minor burns provides protection for skin from wind burn and chapping _WARNINGS_ FOR EXTERNAL USE ONLY Do not use on deep or puncture wounds infections lacerations STOP USE AND ASK A DOCTOR IF redness or swelling develops KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away. _DIRECTIONS_ apply as needed _INACTIVE INGREDIENTS_ Fragrance PETROLATUM JELLY WITH COCOA BUTTER petrolatum jelly PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:52410-0203 Shield Line LLC 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:52410- 0203-2 226 g in 1 JAR; Type 0: Not a Combination Product 06/24/2016 2 NDC:52410- 0203-4 368 g in 1 JAR; Type 0: Not a Combination Product 06/24/2016 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC monograph final part347 06/24/2016 LABELER - Shield Line LLC (078518916) Revised: 2/2021 اقرأ الوثيقة كاملة