SPL v6
SPL
SPL Set ID a7e74b63-9d4c-7baa-e053-2a95a90a98b2
Route
TOPICAL
Published
Effective Date 2020-06-12
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 2020-06-12
Description

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): Alcohol (71%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerol (0.5% v/v). Carbomer (8.0% v/v). Trolamine (1.0% v/v). Sterile distilled water or boiled cold water.

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

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): Alcohol (71%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerol (0.5% v/v). Carbomer (8.0% v/v). Trolamine (1.0% v/v). Sterile distilled water or boiled cold water.

Use

Hand Sanitizer to help reduce bacteria on the skin that potentially can cause sickness, recommended for repeated use.

Section 42229-5

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):

  • Alcohol (71%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Glycerol (0.5% v/v).
  • Carbomer (8.0% v/v).
  • Trolamine (1.0% 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 poison control center right away.

Section 50566-9

Stop use and ask a doctor if irritation and redness develop and presists for more than 72 hours.

Section 50567-7

Avoid contact with eyes, ears, and mouth. If contact does occur, flush with water.



Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours.



Keep out of reach of children. If swallowed, get medical help, or contact poison control center right away.

Warnings

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

Directions
  • Apply a small amount to palms, rubbing briskly to cover both hands until dry - repeat as necessary.
  • Supervise children under 6 years with the use of this product. Do not use on infants.
Other Information
  • Store at room temperature
  • May discolor certain fabrics
  • Harmful to wood finishes and plastics
Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients

Deminerialized water, Carbopol 960, Triethanolamine, Glycerin

Package Label Principal Display Panel

1 gallon / 128 fl oz (3.79 liters) NDC: 78336-070-37

16.9 fl oz (500 ml) NDC: 78336-070-16

8.45 fl oz (250 ml) NDC: 78336-070-08

4.06 fl oz (120 ml) NDC: 78336-070-04

2.03 fl oz (60 ml) NDC: 78336-070-02

1 fl oz (30 ml) NDC: 78336-070-01

1 liter (1000ml) 33.8 fl oz NDC: 78336-070-10

Structured Label Content

Use

Hand Sanitizer to help reduce bacteria on the skin that potentially can cause sickness, recommended for repeated use.

Section 42229-5 (42229-5)

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):

  • Alcohol (71%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Glycerol (0.5% v/v).
  • Carbomer (8.0% v/v).
  • Trolamine (1.0% 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 poison control center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation and redness develop and presists for more than 72 hours.

Section 50567-7 (50567-7)

Avoid contact with eyes, ears, and mouth. If contact does occur, flush with water.



Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours.



Keep out of reach of children. If swallowed, get medical help, or contact poison control center right away.

Purpose

Antiseptic

Warnings

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

Directions
  • Apply a small amount to palms, rubbing briskly to cover both hands until dry - repeat as necessary.
  • Supervise children under 6 years with the use of this product. Do not use on infants.
Other Information (Other information)
  • Store at room temperature
  • May discolor certain fabrics
  • Harmful to wood finishes and plastics
Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

Deminerialized water, Carbopol 960, Triethanolamine, Glycerin

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

1 gallon / 128 fl oz (3.79 liters) NDC: 78336-070-37

16.9 fl oz (500 ml) NDC: 78336-070-16

8.45 fl oz (250 ml) NDC: 78336-070-08

4.06 fl oz (120 ml) NDC: 78336-070-04

2.03 fl oz (60 ml) NDC: 78336-070-02

1 fl oz (30 ml) NDC: 78336-070-01

1 liter (1000ml) 33.8 fl oz NDC: 78336-070-10

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:20.264028 · Updated: 2026-03-14T22:57:50.764620