SCENT THEORY - SCENT X SCENT HAND SANITIZER - WITH 70% ETHYL ALCOHOL (76891-130)

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.

----------

SCENT THEORY - SCENT X SCENT HAND SANITIZER - WITH 70% ETHYL ALCOHOL (76891-130)

ACTIVE INGREDIENT

ETHYL ALCOHOL 70% 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 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 DEGREES F
• MAY DISCOLOR SOME FABRICS
• HARMFUL TO WOOD FINISHES AND PLASTICS

INACTIVE INGREDIENTS

ICED GINGER BREAD: WATER (AUA), CARBOMER, TRIETHANOLAMINE, GLYCERIN, PROPYLENE GLYCOL, FRAGRANCE (PARFUM), ALOE BARBADENSIS LEAF JUICE, TOCOPHERYL ACETATE, YELLOW 5, RED 33.

SUGAR PLUM: WATER (AUA), CARBOMER, TRIETHANOLAMINE, GLYCERIN, PROPYLENE GLYCOL, FRAGRANCE (PARFUM), ALOE BARBADENSIS LEAF JUICE, TOCOPHERYL ACETATE, BLUE 1, RED 33.

CANDY CANE: WATER (AUA), CARBOMER, TRIETHANOLAMINE, GLYCERIN, PROPYLENE GLYCOL, FRAGRANCE (PARFUM), ALOE BARBADENSIS LEAF JUICE, TOCOPHERYL ACETATE, RED 33.

BERRY FROST: WATER (AUA), CARBOMER, TRIETHANOLAMINE, GLYCERIN, PROPYLENE GLYCOL, FRAGRANCE (PARFUM), ALOE BARBADENSIS LEAF JUICE, TOCOPHERYL ACETATE, BLUE 1, YELLOW 5, RED 33.

WINTER FOREST: WATER (AUA), CARBOMER, TRIETHANOLAMINE, GLYCERIN, PROPYLENE GLYCOL, FRAGRANCE (PARFUM), ALOE BARBADENSIS LEAF JUICE, TOCOPHERYL ACETATE, BLUE 1, YELLOW 5.

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76891-130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76891-130-11	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/15/2021

Labeler - SCENT THEORY PRODUCTS LLC (101216246)

Revised: 1/2022

Document Id: d5b85d9f-93d5-1256-e053-2a95a90ac84d

34390-5

Set id: c72d21d7-729a-f742-e053-2a95a90a2ad9

Version: 3

Effective Time: 20220116