Hand Sanitizer by Valor Fractal, LLC Hand Sanitizer

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Valor Fractal, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol gel 
Valor Fractal, 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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Hand Sanitizer

This is a hand sanitizer manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Carbomer 940 (0.40% v/v)
3. Trolamine (0.55% v/v).
4. Sterile distilled water or boiled cold water.

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

to decrease bacteria on the skin that could cause diseases.

Warnings

For external use only. Flammable product. Keep out of reach of children. Keep at a temperature not higher than 105F. May discolor some fabrics, harmful to wood finishes.

Do not use

• in children less than 2 months of age
• on open skin wounds

When using this product: Keep out of eyes. In case of contact, flush thoroughly with water. Do not inhale or ingest.

Stop using and ask a doctor: if irritation and redness develop and presists for more than 24 hours.

Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.

Stop using and ask a doctor: if irritation or redness develop and persists for more than 24 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions: apply a small amount in your hands and rub until it dries, for children under 6, use only under adult supervision.

Other information

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

Inactive ingredients

Purified water USP, Trolamine, Carbomer 940, and other stabilizers.

Package Label - Principal Display Panel

251 mL NDC: 79047-001-01

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79047-001
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
CARBOMER 940 (UNII: 4Q93RCW27E)	0.4 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.55 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79047-001-01	251 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020	07/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/06/2020	07/16/2020

Labeler - Valor Fractal, LLC (114617374)

Establishment
Name	Address	ID/FEI	Business Operations
Valor Fractal, LLC		114617374	manufacture(79047-001)

Revised: 12/2020

Document Id: b7cae347-4426-88ff-e053-2995a90ab743

34390-5

Set id: a9c02dd1-5ffd-2129-e053-2995a90a34dd

Version: 3

Effective Time: 20201231