Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
FOURSTAR GROUP USA, INC.
TOPICAL
OTC DRUG
hand sanitizer to help reduce bacteria on skin
OTC monograph not final
CUPCAKE SCENTED HAND SANITIZER- ALCOHOL GEL FOURSTAR GROUP USA, INC. ---------- CUPCAKE SCENTED HAND SANITIZER GEL _DRUG FACTS_ _ACTIVE INGREDIENT_ Ethyl Alcohol, 70% v/v _PURPOSE_ Antimicrobial _USES_ hand sanitizer to help reduce bacteria on skin _WARNINGS_ FOR EXTERNAL USE ONLY. FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME. DO NOT USE in or near the eyes In case of contact, rinse eyes thoroughly with water. STOP USE AND ASK A DOCTOR IF irritation, excessive redness or rash develops. KEEP OUT OF REACH OF CHILDREN. Supervise children under 6 years of age when using this product to avoid swallowing. If swallowed, get medical help or contact a Poison Control Center right away. _DIRECTIONS_ Put a dime sized drop onto hands and rub together briskly until dry. _OTHER INFORMATION_ Store below 110°F (43°C) _INACTIVE INGREDIENTS_ water, carbomer, fragrance, triethanolamine, blue 1 PACKAGE LABELING: CUPCAKE SCENTED HAND SANITIZER alcohol gel PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:80684-012 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.7 mL in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH WATER (UNII: 059QF0KO0R) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) TROLAMINE (UNII: 9O3K93S3TK) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:80684-012- 01 29 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/17/2020 FOURSTAR GROUP USA, INC. MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC Monograph Drug 505G(a)(3) 12/17/2020 LABELER - FOURSTAR GROUP USA, INC. (140099503) Revised: 10/2023 Läs hela dokumentet