HAND SANITIZER- alcohol gel
UNILEVER ASIA PRIVATE LIMITED

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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LIFEBOUY HAND SANITIZER GEL - 80% ALCOHOL

ACTIVE INGREDIENT

ALCOHOL 80% v/v

PURPOSE

ANTISEPTIC

USES

HAND SANITIZER TO HELP REDUCE BACTERIA THAT POTENTIALLY CAN CAUSE DISEASE. FOR USE WHEN SOAP AND WATER ARE NOT AVAILABLE.

WARNINGS

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

DO NOT USE

ON CHILDREN LESS THAN 2 MONTHS OF AGE
ON OPEN SKIN WOUNDS

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

STOP USE AND A DOCTOR IF IRRITATION OR RASH OCCURS. THESE MAY BE SIGNS OF A SERIOUS CONDITION.

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

PLACE ENOUGH PRODUCT ON HANDS TO COVER ALL SURFACES. RUB HANDS TOGETHER UNTIL DRY.
SUPERVISE CHILDREN UNDER 6 YEARS OF AGE WHEN USING THIS PRODUCT TO AVOID SWALLOWING.

OTHER INFORMATION

STORE BETWEEN 15-30°C (59-86°F)
AVOID FREEZING AND EXCESSIVE HEAT ABOVE 40°C (104°F)

INACTIVE INGREDIENTS

PURIFIED WATER USP, CARBOMER, AMINOMETHYL PROPANOL, DENATONIUM BENZOATE

LB_HandSanitizer_Sinno_Label_50ml

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50069-102(NDC:75497-102)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50069-102-11	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/23/2020
2	NDC:50069-102-12	50 mL in 1 TUBE; Type 0: Not a Combination Product	04/23/2020
3	NDC:50069-102-13	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/23/2020

Labeler - UNILEVER ASIA PRIVATE LIMITED (894632699)