SCENT THEORY - ANTI-BACTERIAL - HAND SANITIZER SPRAY - 65% ETOH (76891-133)

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 spray 
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 - ANTI-BACTERIAL - HAND SANITIZER SPRAY - 65% ETOH (76891-133)

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

• SPRAY HANDS 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 DEGREES F
• MAY DISCOLOR SOME FABRICS
• HARMFUL TO WOOD FINISHES AND PLASTICS

INACTIVE INGREDIENTS

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

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

HAND SANITIZER 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76891-133
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
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
EUCALYPTUS OIL (UNII: 2R04ONI662)
PRUNUS SEROTINA BARK (UNII: 5D48E975HA)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76891-133-11	100 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: 1/2022

Document Id: d5b808bc-ba3f-4047-e053-2a95a90a89a2

34390-5

Set id: d16e4252-b9fa-62e0-e053-2a95a90a05f1

Version: 3

Effective Time: 20220116