SPL v1
SPL
SPL Set ID f82dd433-b8d3-4b84-a90e-cab200bb0f7c
Route
TOPICAL
Published
Effective Date 2020-06-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water Isopropyl Alcohol Glycerin Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Aminomethylpropanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-22
Description

Alcohol 70% v/v. 

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Alcohol 70% v/v. 

Uses

Hand Sanitizer to help reduce bacteria  on the skin.

Section 50565-1

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

Warnings

Flammable. Keep away from fire or flame.

For external use only.

When using this product avoid contact with face, eyes and broken skin. In case of contact, rinse thoroughly with water.

Stop use and ask a doctor if irritation or redness appears and lasts.

Directions
  • Put enough product in your palm to cover hands and rub hands until dry.
  • Children under 6 years of age should be supervised when using the product.
Active Ingredient

Alcohol 70% v/v. 

Other Information
  • Store below 110° F (43° C).
  • May discolor certain fabrics or surfaces.
Inactive Ingredients

Water (Aqua), lsopropyl Alcohol, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, 2-amino-2-methyl-1-propanol.

Package Label Principal Display Panel

Structured Label Content

Uses

Hand Sanitizer to help reduce bacteria  on the skin.

Section 50565-1 (50565-1)

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

Purpose

Antimicrobial

Warnings

Flammable. Keep away from fire or flame.

For external use only.

When using this product avoid contact with face, eyes and broken skin. In case of contact, rinse thoroughly with water.

Stop use and ask a doctor if irritation or redness appears and lasts.

Directions
  • Put enough product in your palm to cover hands and rub hands until dry.
  • Children under 6 years of age should be supervised when using the product.
Active Ingredient

Alcohol 70% v/v. 

Other Information (Other information)
  • Store below 110° F (43° C).
  • May discolor certain fabrics or surfaces.
Inactive Ingredients (Inactive ingredients)

Water (Aqua), lsopropyl Alcohol, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, 2-amino-2-methyl-1-propanol.

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:53.774407 · Updated: 2026-03-14T22:57:10.859448