Kepter Hand Sanitizer

Kepter Hand Sanitizer
SPL v2
SPL
SPL Set ID a73d415c-9c32-b56f-e053-2a95a90abb35
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.5 mL)
Inactive Ingredients
Glycerin Carbomer 940 Water Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-30
Description

This is a hand sanitizer manufactured using only the following United States Pharmacopoeia (USP) grade ingredients: 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. Glycerol (.5% v/v). Carbopol (0.5% v/v). Triethanolamine (0.4% v/v) Sterile distilled water or boiled cold water.

Purpose

Antiseptic, Hand Sanitizer

Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

This is a hand sanitizer manufactured using only the following United States Pharmacopoeia (USP) grade ingredients: 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. Glycerol (.5% v/v). Carbopol (0.5% v/v). Triethanolamine (0.4% v/v) Sterile distilled water or boiled cold water.

Use

Antiseptic Hand Sanitizer to reduce germs on skin. For use when soap and water are not available.

Section 42229-5

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

  • 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.
  • Glycerol (.5% v/v).
  • Carbopol (0.5% v/v).
  • Triethanolamine (0.4% v/v)
  • Sterile distilled water or boiled cold water.

Section 50565-1

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

Section 50566-9

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

Section 50567-7

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, rash or redness 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.

Warnings

For external use only. Flammable. Keep away from open flame and sources of heat.

Directions

Apply a small amount of product into hands and rub between both sides of hands until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Other Information
  • Store below 110F (43C)
  • Avoid freezing. May discolor certain fabrics/surfaces.
Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients

Water, glycerin, carbopol, Triethanolamine.

Package Label Principal Display Panel

976 mL NDC: 75432-003-01

3786 mL NDC: 75432-003-02

Structured Label Content

Use

Antiseptic Hand Sanitizer to reduce germs on skin. For use when soap and water are not available.

Section 42229-5 (42229-5)

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

  • 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.
  • Glycerol (.5% v/v).
  • Carbopol (0.5% v/v).
  • Triethanolamine (0.4% v/v)
  • Sterile distilled water or boiled cold water.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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, rash or redness 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.

Purpose

Antiseptic, Hand Sanitizer

Warnings

For external use only. Flammable. Keep away from open flame and sources of heat.

Directions

Apply a small amount of product into hands and rub between both sides of hands until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Other Information (Other information)
  • Store below 110F (43C)
  • Avoid freezing. May discolor certain fabrics/surfaces.
Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

Water, glycerin, carbopol, Triethanolamine.

Package Label Principal Display Panel (Package Label - Principal Display Panel)

976 mL NDC: 75432-003-01

3786 mL NDC: 75432-003-02

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:00.790837 · Updated: 2026-03-14T22:57:20.173282