SPL v2
SPL
SPL Set ID 34ece294-7ed7-42c3-a29f-9898c64a2509
Route
TOPICAL
Published
Effective Date 2022-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Aloe Vera Leaf Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) D&c Green No. 5 D&c Yellow No. 10 Water Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-28
Description

Ethyl Alcohol 70% v/v

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Ethyl Alcohol 70% v/v

Use

Hand Sanitizer to help reduce bacteria on skin.

Section 50565-1

Warnings

For external use only.

Flammable. Keep away from heat or flame.

Do not use

• In children less than 2 months of age

• On open skin wounds

When using this product avoid mouth, eyes, and ears. In case of contact with eyes, flush 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 and call Poison Control.

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age.
Product Label

Active Ingredient

Ethyl Alcohol 70% v/v

Other Information
  • Store in 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients

Aloe Vera, Carbomer, D&C Green #5, D&C Yellow #10, Water, Trolamine

Structured Label Content

Use

Hand Sanitizer to help reduce bacteria on skin.

Section 50565-1 (50565-1)

Purpose

Antimicrobial

Warnings

For external use only.

Flammable. Keep away from heat or flame.

Do not use

• In children less than 2 months of age

• On open skin wounds

When using this product avoid mouth, eyes, and ears. In case of contact with eyes, flush 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 and call Poison Control.

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age.
Product Label (Product label)

Active Ingredient

Ethyl Alcohol 70% v/v

Other Information (Other information)
  • Store in 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients (Inactive ingredients)

Aloe Vera, Carbomer, D&C Green #5, D&C Yellow #10, Water, Trolamine

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:16.782409 · Updated: 2026-03-14T23:00:39.941399