Sanitizer by Aromas para El Alma S.A. HAND SANITIZER 60 ML

Sanitizer by

Drug Labeling and Warnings

Sanitizer by is a Otc medication manufactured, distributed, or labeled by Aromas para El Alma S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SANITIZER- sanitizer gel 
Aromas para El Alma S.A.

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.

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HAND SANITIZER 60 ML

USAGE

FOR HAND CLEANSING TO DECREASE BACTERIA ON THE SKIN

WARNINGS

FOR EXTERNAL USE ONLY

FLAMMABLE, KEEP AWAY FROM FIRE AND FLAME

DO NOT USE IN THE EYES

KEEP OUT OF REACH OF CHILDREN

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY

INACTIVE INGREDIENTS

WATER, CARBOMER, AMINOMETHYL PROPANOL, GLYCERIN, ORGANIC EUCALYPTUS LEAF OIL

KEEP OUT OF REACH

KEEP OUT OF REACH OF CHILDREN

STOP USE AND ASK A DOCTOR IF

STOP USE AND ASK A DOCTOR IF

- IRRITATION AND REDNESS DEVELOP

- CONDITION PERSISTS FOR MORE THAN 72 HOURS

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY

PURPOSE

ANTISEPTIC

DOSAGE

WET HANDS THOROUGHLY WITH PRODUCT AND ALLOW TO DRY WITHOUT WIPING

ACTIVE INGREDIENT

ETHYL ALCOHOL 70%

OTHER INFORMATION

STORE BELOW 110 F ( 43 C)

MAY DISCOLOR CERTAIN FABRICS

PACKAGE OUTSIDE LABEL

SANITIZER 
sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80751-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
WATER (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80751-200-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/01/2020

Labeler - Aromas para El Alma S.A. (853174212)

Revised: 10/2020

Document Id: b190c0fc-5f3e-5ae1-e053-2a95a90ac7e4

34390-5

Set id: b190c0fc-5f3d-5ae1-e053-2a95a90ac7e4

Version: 1

Effective Time: 20201013