HAND SANITIZER- ethyl alcohol gel
Pride Products Corp.

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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PRIDE PRODUCTS - HAND SANITIZER (58037-102)

ACTIVE INGREDIENT

ETHYL ALCOHOL 62.0%

PURPOSE

ANTIMICROBIAL

USES

HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN

WARNINGS

FOR EXTERNAL USE ONLY

FLAMMABLE. KEEP AWAY FROM HEAT AND FLAME.

WHEN USING THIS PRODUCT AVOID CONTACT WITH FACE, EYES, AND BROKEN SKIN. IN CASE OF EYE CONTACT, FLUSH WITH PLENTY OF WATER AND SEEK MEDICAL ADVICE.

STOP USE AND ASK A DOCTOR IF IRRITATION OR REDNESS DEVELOPS.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

DIRECTIONS

WET HANDS THOROUGHLY WITH PRODUCT AND RUB INTO SKIN UNTIL DRY.
CHILDREN UNDER 6 YEARS OF AGE SHOULD BE SUPERVISED BY AN ADULT WHEN USING THIS PRODUCT.

INACTIVE INGREDIENTS

WATER (AQUA), ALOE BARBADENSIS LEAF JUICE, CARBOMER, FRAGRANCE, GLYCERIN, PROPYLENE GLYCOL, TOCOPHERYL ACETATE (VITAMIN E), TRIETHANOLAMINE, FD&C BLUE NO. 1, FD&C YELLOW NO. 5.

01b LBL_Hand Sanitizer_8oz

HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58037-102
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58037-102-11	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/27/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/27/2020

Labeler - Pride Products Corp. (109020099)