HAND SANITIZER- alcohol gel

United States - English - NLM (National Library of Medicine)

Buy It Now

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
Authorization number:
70956-018-01

Read the complete document

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.

PRINCIPAL DISPLAY PANEL - 250 ml Bottle Label

projectc.u.r.e.

www.projectcure.org

HAND SANITIZER

70% ALCOHOL

NDC: XXXXXXX

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 ting End Date

OTC MONOGRAPH NOT FINAL part333A

0 1/12/20 20

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

Labeler -

Absara Cosmetics S.A.P. de C.V. (816161236)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Absara Co smetics S.A.P. de C.V.

8 16 16 1236

MANUFACTURE(70 9 56 -0 18 )

Revised: 11/2020

Similar products

Search alerts related to this product

View documents history

Share this information