CUPCAKE SCENTED HAND SANITIZER- alcohol gel

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)

MAH:

FOURSTAR GROUP USA, INC.

administration_route:

TOPICAL

prescription_type:

OTC DRUG

therapeutic_indication:

hand sanitizer to help reduce bacteria on skin

authorization_status:

OTC monograph not final

SPC

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