MARY JO - CELL CANDY - ADVANCED HAND SANITIZER 80 PERCENT- alcohol gel
MAREK HEWRYK LLC

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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MARY JO - CELL CANDY - ADVANCED HAND SANITIZER - ALCOHOL 80%

ACTIVE INGREDIENT

ALCOHOL 80% W/V

PURPOSE

ANTISEPTIC

USE(S)

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

IN 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 WITH EYES, RINSE EYES THOROUGHLY WITH WATER.

STOP USE AND ASK 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 15-30C (59-86F)
AVOID FREEZING AND EXCESSIVE HEAT ABOVE 40C (104F)

INACTIVE INGREDIENTS

GLYCERIN, HYDROGEN PEROXIDE, PURIFIED WATER USP, ALOE BARBADENSIS (ALOE VERA) LEAF JUICE, CARBOMER, TOCOPHERYL ACETATE (VIT. E), ANTHEMIS NOBILIS (CHAMOMILE) EXTRACT, TILIA CORDATA (LINDEN) EXTRACT, FRAGRANCE (PARFUM)

01b LBL_Hand-Sanitizer_Mary Jo

MARY JO - CELL CANDY - ADVANCED HAND SANITIZER 80 PERCENT
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75161-102
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
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75161-102-11	225 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/29/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/29/2020

Labeler - MAREK HEWRYK LLC (033217270)

Name	Address	ID/FEI	Business Operations
Establishment
MAREK HEWRYK LLC		033217270	manufacture(75161-102)