Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)
Kroger
TOPICAL
OTC DRUG
Skin Protectant Temporarily protects chapped or cracked lips. Helps protect lips from drying effects of wind and cold weather.
OTC monograph final
KROGER LIP TREATMENT- PETROLATUM GEL KROGER _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 Petrolatum, 100% PURPOS E Skin Protectant KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away. US ES Temporarily protects chapped or cracked lips. Helps protect lips from drying effects of wind and cold weather. WARNINGS FOR EXTERNAL USE ONLY. When using this product –Do not get into eyes. Stop use and ask a doctor if – condition worsens-symptoms last more than 7 days or clear up and occur again within a few days. DIRECTIONS Apply as needed. INACTIVE INGREDIENTS Flavor PACKAGE/LABEL PRINCIPAL DISPLAY PANEL KROGER LIP TREATMENT petrolatum gel PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:30 142-9 30 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 8 mg in 1 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH METHYL SALICYLATE (UNII: LAV5U50 22Y) 0 .0 2 mg in 1 g PRODUCT CHARACTERISTICS COLOR WHITE S CORE S HAP E S IZ E FLAVOR IMPRINT CODE CONTAINS PACKAG ING Kroge r # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:30 142-9 30 -0 3 1 g in 1 TUBE 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 5/0 2/20 13 LABELER - Kroger (006999528) REGISTRANT - OraLabs (801824756) ESTABLISHMENT NAME AD D RE S S ID/FEI BUSINE SS OPE RATIONS O ra La bs 8 0 18 24756 MANUFACTURE(30 142-9 30 ) , LABEL(30 142-9 30 ) Revised: 4/2013 Perskaitykite visą dokumentą