MOISTURIZING HAND SANITIZER WITH ALOE 62 PERCENT- ethyl alcohol gel
SCENT THEORY PRODUCTS 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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SCENT THEORY - MOISTURIZING HAND SANITIZER WITH ALOE - 62% ETHYL ALCOHOL (76891-117)

ACTIVE INGREDIENT

ETHYL ALCOHOL 62%

PURPOSE

ANTISEPTIC

USES

decreases bacteria on the skin that could cause disease
recommended for repeated use

WARNINGS

For external use only: hands

Flammable. Keep away from fire or flame.

When using this product

Keep out of eyes. In case of contact with eyes flush thoroughly with water.
Avoid contact with broken skin.
Do not inhale or ingest.

Stop use and ask a doctor if

irritation and redness develop
condition persists for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

WET HANDS THOROUGHLY WITH PRODUCT AND ALLOW TO DRY WITHOUT WIPING.
FOR CHILDREN UNDER 6, USE ONLY UNDER ADULT SUPERVISION.
NOT RECOMMENDED FOR INFANTS.

OTHER INFORMATION

DO NOT STORE ABOVE 105°F
MAY DISCOLOR SOME FABRICS
HARMFUL TO WOOD FINISHES AND PLASTICS

INACTIVE INGREDIENTS

Water (Aqua), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glycerin, Triethanolamine, Fragrance (Parfum), Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Denatonium Benzoate, Phenoxyethanol, Ethylhexylglycerin, Yellow 5 (CI 19140), Blue 1 (CI 42090)

01b LBL_ST_Keep Clean w-Aloe_12oz

MOISTURIZING HAND SANITIZER WITH ALOE 62 PERCENT
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76891-117
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
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76891-117-11	89 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020
2	NDC:76891-117-12	360 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020
3	NDC:76891-117-13	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020
4	NDC:76891-117-14	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/30/2020

Labeler - SCENT THEORY PRODUCTS LLC (101216246)