Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)
Denison Pharmaceuticals, LLC
TOPICAL
OTC DRUG
Skin Protectant - temporarily protects and helps relieve chapped or cracked skin - helps prevent and protect from the drying effects of wind and cold weather - if condition lasts more than 7 days - deep or punctured wounds - animal bites - serious burns
OTC monograph final
HYDROLATUM- WHITE PETROLATUM CREAM DENISON PHARMACEUTICALS, 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._ ---------- HYDROLATUM White Petrolatum, 54% Skin Protectant temporarily protects and helps relieve chapped or cracked skin helps prevent and protect from the drying effects of wind and cold weather for external use only Keep out of reach of children Stop using if allergic do not get into eyes do not get into mouth if condition lasts more than 7 days apply as needed Store at 20-25C (68-77F) Methylparaben, Purified Water, Sorbitan Sesquioleate Call Toll Free at 1-800-601-3843 or email complaints@dpharm.net deep or punctured wounds animal bites serious burns Keep out of reach of children HYDROLATUM white petrolatum cream PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:0 29 5-9 374 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 45 g in 10 0 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) SO RBITAN SESQ UIO LEATE (UNII: 0 W8 RRI5W5A) METHYLPARABEN (UNII: A2I8 C7HI9 T) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE Denison Pharmaceuticals, LLC 1 NDC:0 29 5-9 374-13 57 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct 0 2/19 /20 20 2 NDC:0 29 5-9 374-36 454 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct 0 2/19 /20 20 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 rt346 0 2/19 /20 20 LABELER - Denison Pharmaceuticals, LLC (001207208) ESTABLISHMENT NAME AD D RE S S ID/FEI BUSINE SS OPE RATIONS Deniso n Pharmaceuticals, LLC 0 0 120 720 8 ma nufa c ture (0 29 5-9 374) Revised: 7/2020 Prečítajte si celý dokument