SCENT THEORY - HAND SANITIZER GEL - 65% ETOH (76891-132)

HAND SANITIZER by

Drug Labeling and Warnings

HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by SCENT THEORY PRODUCTS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- 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 - HAND SANITIZER GEL - 65% ETOH (76891-132)

ACTIVE INGREDIENT

ETHYL ALCOHOL 65% V/V

PURPOSE

ANTISEPTIC

USES

• FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN

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 immediately.

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.

INACTIVE INGREDIENTS

Vanilla Coconut: Water, Glycerin, Aloe Barbadensis Leaf Juice, Fragrance, Carbomer, Aminomethyl propanol, Cocos Nucifera (Coconut) Oil, Denatonium Benzoate

Lemon Cloudberry: Water, Glycerin, Aloe Barbadensis Leaf Juice, Fragrance, Carbomer, Aminomethyl propanol, Citrus Medica Limonum (Lemon) Peel Oil ,Denatonium Benzoate

Lavender Geranium: Water, Glycerin, Aloe Barbadensis Leaf Juice, Fragrance, Carbomer, Aminomethyl propanol, Lavandula Angustifolia (Lavender) Oil, Denatonium Benzoate

Wild Black Cherry: Water, Glycerin, Aloe Barbadensis Leaf Juice, Fragrance, Carbomer, Aminomethyl propanol, Prunus Serotina (Wild Cherry) Bark Extract, Denatonium Benzoate

Eucalyptus Woods: Water, Glycerin, Aloe Barbadensis Leaf Juice, Fragrance, Carbomer, Aminomethyl propanol, Eucalyptus Globulus Leaf Oil, Denatonium Benzoate

OTHER INFORMATION

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

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76891-132
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
COCONUT OIL (UNII: Q9L0O73W7L)
LAVENDER OIL (UNII: ZBP1YXW0H8)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
PRUNUS SEROTINA BARK (UNII: 5D48E975HA)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76891-132-11	295 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/22/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/22/2021

Labeler - SCENT THEORY PRODUCTS LLC (101216246)

Revised: 11/2022

Document Id: ec7173bc-c741-4094-e053-2a95a90a2ac9

34390-5

Set id: d16d22bd-06a7-4ab3-e053-2995a90a69ef

Version: 4

Effective Time: 20221101