DGP High Performance Hand Sanitizer by Dynamic Green Products, Inc. / Viking Chemical Co. / Dynamic Green Products Inc.

DGP High Performance Hand Sanitizer by

Drug Labeling and Warnings

DGP High Performance Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Dynamic Green Products, Inc., Viking Chemical Co., Dynamic Green Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DGP HIGH PERFORMANCE HAND SANITIZER- ethyl alcohol gel 
Dynamic Green Products, 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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This is a hand sanitizer manufactured according to an OTC monograph not final (part333A).

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation):

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (77.35%, weight/weight (w/w)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Ethyl Lactate (19.34% w/w).
3. Glycerin (2% w/w).
4. .Alpha.-Tocopherol Acetate (.03% w/w).
5. Hydroxypropyl cellulose (.08% w/w).

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 77.35% w/w. Purpose: Antiseptic

Purpose

Hand and Skin Antiseptic

Hand and Skin Antiseptic to help decrease pathogens (germs) on the skin

For External Use Only

Use

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

Warnings

Flammable. Keep away from heat or flame

Do not use

• Avoid contact with eyes.
• If contact occurs, flush eyes with water.
• If swallowed, get medical help or contact a Poison Control Center immediately.

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Ask a doctor before use if you have open wounds or serious burns. Stop use and ask a doctor if irritation or redness develops. 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.

Stop use and ask a doctor if irritation or redness develops. These may be signs of a serious condition.

Children should be supervised when using this product. 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 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

ethy lactate, glycerin, alpha tocopherol acetate, hydroxypropyl cellulose, fragrance

Package Label - Principal Display Panel

000 mL NDC: 74631-002-XX

DGP HIGH PERFORMANCE HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74631-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	76 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYL LACTATE (UNII: F3P750VW8I)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74631-002-25	00 mL in 1 TANK; Type 0: Not a Combination Product	04/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/28/2020	07/31/2020

Labeler - Dynamic Green Products, Inc. (110949053)

Registrant - Viking Chemical Co. (025807272)

Establishment
Name	Address	ID/FEI	Business Operations
Viking Chemical Co.		025807272	manufacture(74631-002)

Establishment
Name	Address	ID/FEI	Business Operations
Dynamic Green Products Inc.		110949053	pack(74631-002) , label(74631-002)

Revised: 11/2021

Document Id: d1f19dd4-69e4-0fc0-e053-2a95a90ae0eb

34390-5

Set id: a3e3b00b-6689-78c3-e053-2a95a90aaf31

Version: 3

Effective Time: 20211129