HAND SANITIZER- alcohol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Absara Cosmetics S.A.P. de C.V.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antimicrobial Hand sanitizer to help reduce bacteria on the skin.

Authorization status:

OTC monograph not final

Summary of Product characteristics

HAND SANITIZER- ALCOHOL GEL
ABSARA COSMETICS S.A.P. DE C.V.
_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._
----------
HAND SANITIZER
DRUG FACTS
ACTIVE INGREDIENT
Ethyl alcohol 70% v/v
PURPOS E
Antimicrobial
US E
Hand sanitizer to help reduce bacteria on the skin.
WARNINGS
FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME. FOR EXTERNAL USE ONLY. Do not
ingest, if swallowed seek
medical help. Avoid contact with eyes.
Keep out of reach of children. Children under 6yrs old to use under
adult supervision. In case of
irritation, discontinue use and consult your doctor.
DIRECTIONS
Apply the gel on the hands and rub gently for 20 seconds until the
product evaporates.
OTHER INFORMATION
Store below 106ºF (41 ºC). May discolor certain fabrics or surfaces.
INACTIVE INGREDIENTS
Demineralized water, glycerin, carbomero,
fragrance, trietanolamina, dmdm hydantoin, aloe
barbadensis extract, iodopropynyl butylcarbamate.
1
PRINCIPAL DISPLAY PANEL - 250 ML BOTTLE LABEL
projectc.u.r.e.
www.projectcure.org
HAND SANITIZER
70% ALCOHOL
NDC: XXXXXXX
1
May contain this ingredient.
8.45 FL OZ
(250ml)
HAND SANITIZER
alcohol gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:70 9 56 -0 18
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)
ALCOHOL
70 mL in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
GLYCERIN (UNII: PDC6 A3C0 OX)
DMDM HYDANTO IN (UNII: BYR0 546 TOW)
IO DO PRO PYNYL BUTYLCARBAMATE (UNII: 6 0 3P14DHEB)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:70 9 56 -0 18 -0 1 250 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio
n Pro duct
0 1/12/20 20
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE
MARKE