SNTZR- alcohol gel 
Applichem, 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 the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

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) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, 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. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

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)

Medicinal ingredient: Ethyl alcohol 70% 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 heat or flame

Do not use

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 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 rash occurs. 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

Other information

Inactive ingredients

Water (Aqua), Glycerin, Hydrogen Peroxide, Alkyl Acrylate Crosspolymer, Triethanolamine, Aloe, Lauryl Alcohol, Myristyl Alcohol, Fragrance (Parfum), PEG Dimethicone

Package Label - Principal Display Panel

1 Gallon3800 mL NDC: 74751-006-01

SNTZR 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74751-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70.6586 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.2665 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.3344 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.1258 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) 0.0216 mL  in 100 mL
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED) 0.0187 mL  in 100 mL
MYRISTYL LACTATE (UNII: 1D822OC34X) 0.2656 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.6023 mL  in 100 mL
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C) 7.6152 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74751-006-013800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/12/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/12/2020
Labeler - Applichem, Inc (039829528)

Revised: 11/2020
Document Id: b4037c29-fc32-9f66-e053-2a95a90af907
Set id: acb4ee8b-6dde-d045-e053-2995a90a56e9
Version: 2
Effective Time: 20201113
 
Applichem, Inc