国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)
Winco
TOPICAL
OTC DRUG
Skin Protectant Helps prevent and temporarily protect dry, chapped or windburned lips.
OTC monograph final
WINCO ORIGINAL PETROLATUM- PETROLATUM STICK WINCO _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, 45% PURPOSE Skin Protectant KEEP OUT OF REACH OF CHILDREN If swallowed get medical help or contact a Poison Control Center right away. USES Helps prevent and temporarily protect dry, chapped or windburned lips. WARNINGS For external use only. Stop use and ask a doctor if rash or irritation develops and lasts. Children under 6 months of age: Ask a doctor before use. DIRECTIONS Apply as needed. INACTIVE INGREDIENTS Camphor, Cetyl Alcohol, Copernicia Cerifera (Carnauba) Wax, Euphorbia Cerifera (Candelilla) Wax, Flavor, Isopropyl Myristate, Lanolin, Microcrystalline Wax, Mineral Oil, Ozokerite, Phenyl Trimethicone, Red 6 Lake (CI 15850), Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140). PACKAGE/LABEL PRINCIPAL DISPLAY PANEL WINCO ORIGINAL PETROLATUM petrolatum stick PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:67091-253 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 45 mg in 1 g INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH LIGHT MINERAL OIL (UNII: N6K5787QVP) 28 ug in 1 g WHITE WAX (UNII: 7G1J5DA97F) 17.5 mg in 1 g MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) 3.0 mg in 1 g LANOLIN (UNII: 7EV65EAW6H) 1.0 mg in 1 g PRODUCT CHARACTERISTICS COLOR PINK SCORE SHAPE SIZE FLAVOR IMPRINT CODE CONTAINS Winco PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:67091-253- 01 1 g in 1 CONTAINER; Type 0: Not a Combination Product 06/15/2023 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC monograph final part347 06/15/2023 LABELER - Winco (056098817) REGISTR 阅读完整的文件