Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: 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 Do not use on - deep or puncture wounds - infections - lacerations - redness or swelling develops
OTC monograph final
PETROLATUM JELLY WITH LAVENDER- 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 99.9% _PURPOSE_ 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 INGREDIENT fragnance PETROLATUM JELLY WITH LAVENDER petrolatum jelly PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:52410 -0 20 7 SHIELD LINE LLC 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 9 9 .9 g in 10 0 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:52410 -0 20 7-2 226 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct 0 6 /21/20 16 2 NDC:52410 -0 20 7-4 36 8 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct 0 6 /21/20 16 MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE OTC mo no graph final pa rt347 0 6 /21/20 16 LABELER - SHIELD LINE LLC (078518916) Revised: 11/2018 Perskaitykite visą dokumentą