HAND SANITIZER- alcohol gel

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

GFA Production (Xiamen) Co., Ltd.

Podání:

TOPICAL

Druh předpisu:

OTC DRUG

Terapeutické indikace:

- For handwashing to decrease bacteria on the skin - Recommended for repeated use.

Stav Autorizace:

OTC monograph not final

Charakteristika produktu

HAND SANITIZER- ALCOHOL GEL
GFA PRODUCTION (XIAMEN) CO., LTD.
----------
HAND SANITIZER
_DRUG FACTS_
_ACTIVE INGREDIENT_
Ethyl alcohol 62 v/v
_PURPOSE_
Antiseptic
_USES_
For handwashing to decrease bacteria on the skin
Recommended for repeated use.
WARNINGS
Flammable. Keep away from fire or flame
FOR EXTERNAL USE ONLY.
DO NOT USE
in the eyes.
STOP USE AND ASK A DOCTOR IF
irritation or redness develop
condition persists for more than 72 hours
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
_DIRECTIONS_
Wet hands thoroughly with product and allow to dry without wiping.
OTHER INFORMATION
Store between 15-25°C (59 to 77°F)
_INACTIVE IGREDIENTS_
o
Carbomer, propylene glycol, purified water, titanium dioxide
_​PACKAGE LABELING:_
HAND SANITIZER
alcohol gel
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:50814-050
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
ALCOHOL
0.62 mL in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GFA Production (Xiamen) Co., Ltd.
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:50814-050-
02
200 mL in 1 BOTTLE; Type 0: Not a Combination
Product
03/01/2020
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC Monograph Drug
505G(a)(3)
03/01/2020
LABELER -
GFA Production (Xiamen) Co., Ltd. (421256261)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
GFA Production (Xiamen) Co., Ltd.
421256261
manufacture(50814-050)
Revised: 10/2023