BAMA BIO TECH HAND SANITIZER 70 ETHANOL LEMONGRASS SCENT- alcohol gel
Bama-Bio Tech Corporation

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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Bama-Bio Tech Hand Sanitizer 70% Ethanol LemonGrass Scent

DRUG FACTS

ACTIVE INGREDIENT[S]

ALCOHOL 70% v/v

PURPOSE

ANTISEPTIC

USE[S]

HEALTHCARE PERSONNEL HAND RUB TO HELP REDUCE BACTERIA THAT POTENTIALLY CAN CAUSE DISEASE.

WARNINGS

FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM HEAT OR FLAME.

DO NOT USE

ON CHILDREN UNDER 2 MONTHS OF AGE
ON OPEN SKIN WOUNDS

WHEN USING THIS PRODUCT

KEEP OUT OF EYES, EARS, AND MOUTH. IN CASE OF CONTACT WITH EYES, RINSE EYES THOROUGHLY WITH WATER.

STOP USE AND CONTACT A PHYSICIAN

IF IRRITATION OR RASH OCCUR.

KEEP OUT OF REACH OF CHILDREN

IF SWALLOWED, CALL POISON CONTROL IMMEDIATELY.

DIRECTIONS

PLACE PRODUCT ON HANDS TO COVER ALL SURFACES. RUB HANDS TOGETHER UNTIL DRY. SUPERVISE USE CHILDREN UNDER 6 YEARS OF AGE.

OTHER INFORMATION

STORE BETWEEN 15-30°C (59-86°F)

INACTIVE INGREDIENTS

PURIFIED WATER USP, GLYCERIN, LAURYL LACTATE, HYDROXYPROPYLCELLULOSE (HPC), ALOE VERA GEL, HYDROGEN PEROXIDE, NATURAL ESSENTIAL OILS.

Package Labeling:

Label9

BAMA BIO TECH HAND SANITIZER 70 ETHANOL LEMONGRASS SCENT
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:90085-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
LAURYL LACTATE (UNII: G5SU0BFK7O)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:90085-002-01	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	07/31/2020

Labeler - Bama-Bio Tech Corporation (117525750)

Name	Address	ID/FEI	Business Operations
Establishment
Bama-Bio Tech Corporation		117525750	manufacture(90085-002)