CREATIVE CHEMICALS ULTRA HAND SANITIZER

Ultra Hand Sanitizer by

Drug Labeling and Warnings

Ultra Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Creative Chemicals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ULTRA HAND SANITIZER- ethyl alcohol liquid 
Creative Chemicals, Inc.

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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CREATIVE CHEMICALS ULTRA HAND SANITIZER

Drug Facts

Active Ingredient

Ethyl Alcohol (Ethanol) 80% 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

External use only. Flammable. Keep away from heat or flame.

Do not use

on 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 or rash occurs. These may be a 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 briskly until dry

Children under 6 years of age should be supervised 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: Glycerin, Hydrogen Peroxide, Purified Water USP

80% ETHANOL FORMULA

ALCOHOL ANTISEPTIC TOPICAL

KEEP OUT OF REACH OF CHILDREN

For Emergencies, Call 24hr ChemTel: 800-255-3924

Manufactured By:

Creative Chemicals, Inc.

88 Winter St., Holyoke, MA 01040

DIRECTIONS FOR USE
Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry. Children under 6 years of age should be supervised when using this product. Store 15-30 C (59-86 F). May discolor certain fabrics or surfaces.

WARNING

Warnings. Flammable. Keep away from fire or flame. For external use only. When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash appears and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Packaging

ULTRA HAND SANITIZER 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79685-801
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79685-801-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2020	12/23/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/30/2020	12/23/2023

Labeler - Creative Chemicals, Inc. (057988115)

Establishment
Name	Address	ID/FEI	Business Operations
Creative Chemicals, Inc.		057988115	manufacture(79685-801)

Revised: 12/2021

Document Id: 8eab3ddd-c06a-4ac7-a624-eee572992614

34390-5

Set id: 5bed13b6-b2ae-41a0-a3cb-eadff0c01095

Version: 2

Effective Time: 20211220