Frozen II Winterberry Scented Hand Sanitizer by Taste Beauty LLC Drug Facts

Frozen II Winterberry Scented Hand Sanitizer by

Drug Labeling and Warnings

Frozen II Winterberry Scented Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Taste Beauty LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FROZEN II WINTERBERRY SCENTED HAND SANITIZER- alcohol gel 
Taste Beauty 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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Drug Facts

Active ingredient

Alcohol Denat. 62% v/v

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only.

Flammable. Keep away from fire and flames.

Do not use

• In children less than 2 months of age
• On open skin wounds

When using this product

• Keep out of eyes, ears and mouth.
• In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if

• Irritation and redness develop.

These may be signs of a serious condition.

Keep out of reach of children.

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

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30°C (59-86°F)
• Avoid freezing and excessive heat above 40°C(104°F)

Inactive ingredients

Water/Aqua/Eau, Fragrance/Parfum, PEG-40 Hydrogenated Castor Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Denatonium Benzoate, D&C Red No.33 (Cl 17200), FD&C Blue No. 1 (Cl 42090)

Principal Display Panel – 30 mL Bottle Label

ELSA

THE
SNOW QUEEN

Winterberry
Hand Sanitizer

1 FL OZ/30 mL

FROZEN II WINTERBERRY SCENTED HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74825-9020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Polyethylene Glycol 2000 (UNII: HAF0412YIT)
Hydrogenated Castor Oil (UNII: ZF94AP8MEY)
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)
Sodium Hydroxide (UNII: 55X04QC32I)
Denatonium Benzoate (UNII: 4YK5Z54AT2)
D&C Red No. 33 (UNII: 9DBA0SBB0L)
FD&C Blue No. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74825-9020-1	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/31/2020	12/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/31/2020	12/31/2023

Labeler - Taste Beauty LLC (080073601)

Revised: 1/2022

Document Id: 758c7e84-0ad6-43aa-a9b4-60edcff5d840

34390-5

Set id: 83393ccc-ad51-4130-9d12-22abc964ec8a

Version: 2

Effective Time: 20220131