ANTIBACTERIAL by AROMAS PARA EL ALMA S.A. ANTIBACTERIAL SPRAY 60ML

ANTIBACTERIAL by

Drug Labeling and Warnings

ANTIBACTERIAL 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]

ANTIBACTERIAL- antibacterial liquid 
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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ANTIBACTERIAL SPRAY 60ML

DOSAGE DIRECTIONS

SPRAY HANDS OR BODY WITH PRODUCT AS MANY TIMES AS NEEDED

WARNINGS

FOR EXTERNAL USE ONLY

FLAMMABLE, KEEP AWAY FROM FIRE AND FLAME

DO NOT USE IN THE EYES

INACTIVE INGREDIENT

WATER, GLYCERIN, CITRUS GRANDIS SEED EXTRACT,

LEMON PEEL OIL, ROSEMARY LEAF OIL,

ORGANIC EUCALYPTUS LEAF OIL,

ORGANIC CLOVE BUD FLOWER OIL

ORGANIC CINNAMON LEAF OIL

USAGE

FOR HAND CLEANSING TO DECREASE BACTERIA ON THE SKIN

KEEO OUT OF REACH

KEEP OUT OF REACH OF CHILDREN

PURPOSE

ANTISEPTIC

ASK DOCTOR

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

ACTIVE INGREDIENT

ETHYL ALCOHOL 60%

OUTER PRODUCT LABEL

ANTIBACTERIAL 
antibacterial liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80751-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	60 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CITRUS FRUIT (UNII: XDK00Z8012)	3 mL  in 100 mL
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)	1 mL  in 100 mL
CLOVE LEAF OIL (UNII: VCA5491KVF)	1 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	29 mL  in 100 mL
CINNAMON OIL (UNII: E5GY4I6YCZ)	0.5 mL  in 100 mL
LEMON OIL (UNII: I9GRO824LL)	3 mL  in 100 mL
ROSEMARY (UNII: IJ67X351P9)	1 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80751-300-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2020
2	NDC: 80751-300-07	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/26/2020

Labeler - AROMAS PARA EL ALMA S.A. (853174212)

Revised: 10/2020

Document Id: b25f0393-c31d-896c-e053-2995a90aa47d

34390-5

Set id: b25f0393-c31c-896c-e053-2995a90aa47d

Version: 1

Effective Time: 20201023