SCENT THEORY - HAND SANITIZER GEL - 62% ETOH, Bamboo Mist, Water Melon Kiwi, Sea Salt Lavender, Lemon Lime Spritz, Coconut Coast (76891-134)

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 ALL VARIANTS- 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 - 62% ETOH, Bamboo Mist, Water Melon Kiwi, Sea Salt Lavender, Lemon Lime Spritz, Coconut Coast (76891-134)

ACTIVE INGREDIENT

ETHYL ALCOHOL 62% 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

Bamboo Mist: Water (Aqua), Glycerin, Aloe Barbadensis Leaf Juice, Fragrance (Parfum), Carbomer, Aminomethyl propanol, Denatonium Benzoate, Yellow 5, Blue 1

Lemon Lime Spritz: Water (Aqua), Glycerin, Aloe Barbadensis Leaf Juice, Fragrance (Parfum), Carbomer, Aminomethyl propanol, Denatonium Benzoate, Yellow 10

Sea Salt Lavender: Water (Aqua), Glycerin, Aloe Barbadensis Leaf Juice, Fragrance (Parfum), Carbomer, Aminomethyl propanol, Denatonium Benzoate, Red 33, Blue 1

Water Melon Kiwi: Water (Aqua), Glycerin, Aloe Barbadensis Leaf Juice, Fragrance (Parfum), Carbomer, Aminomethyl propanol, Denatonium Benzoate, Red 33, Red 40

Coconut Coast: Water (Aqua), Glycerin, Aloe Barbadensis Leaf Juice, Fragrance (Parfum), Carbomer, Aminomethyl propanol, Denatonium Benzoate, Yellow 5, Blue 1

OTHER INFORMATION

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

HAND SANITIZER  ALL VARIANTS
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76891-134
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76891-134-11	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/11/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/11/2022

Labeler - SCENT THEORY PRODUCTS LLC (101216246)

Registrant - SCENT THEORY PRODUCTS LLC (101216246)

Revised: 11/2022

Document Id: ed39e84f-d8c2-9575-e053-2a95a90a7a33

34390-5

Set id: ed39e84f-d8c3-9575-e053-2a95a90a7a33

Version: 1

Effective Time: 20221111