Consumer Hand Sanitizer; Non-emergency; Isopropyl Alcohol = Deferred Grase Active Ingredient Determination Effective April 13, 2020; Part333e For Otc Hand Rub Sanitizers (consumer)

Consumer Hand Sanitizer; Non-emergency; Isopropyl Alcohol = Deferred Grase Active Ingredient Determination Effective April 13, 2020; Part333e For Otc Hand Rub Sanitizers (consumer)
SPL v1
SPL
SPL Set ID a2f403a1-6e9b-e2a3-e053-2a95a90ac6f9
Route
TOPICAL
Published
Effective Date 2020-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (1 mL)
Inactive Ingredients
Limonene, (+)- Glycerin Aloe Vera Leaf Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-30
Description

Isopropyl Alcohol 70% v/v

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Isopropyl Alcohol 70% v/v

Use(s)

To help reduce bacteria on the skin. For use when soap and water are not available.

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs.

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.

  • avoid contact with broken skin
  • do not inhale or ingest
Section 50570-1

Do not use

  • on children less than 2 months of age
  • on open skin wounds
  • around eyes
  • in ears and mouth
Section 51945-4

ANTISEPTIC

HAND

SANITIZER

SPRAY GEL

ALCOHOL ANTISEPTIC 70%

enriched with aloe

CLEAN SCENT

TOPICAL SOLUTION

KILLS

GERMS &

BACTERIA

3.4OZ 100ML

NO-STERILE SOLUTION

Warnings

For external use only.

Flammable. Keep away from heat or flame

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F).
Active Ingredient(s)

Isopropyl Alcohol 70% v/v

Inactive Ingredients

Aloe Barbadensis (leaf) Extract, Fragrance, Glycerin, Purified Water

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Use(s)

To help reduce bacteria on the skin. For use when soap and water are not available.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs.

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.

  • avoid contact with broken skin
  • do not inhale or ingest
Section 50570-1 (50570-1)

Do not use

  • on children less than 2 months of age
  • on open skin wounds
  • around eyes
  • in ears and mouth
Section 51945-4 (51945-4)

ANTISEPTIC

HAND

SANITIZER

SPRAY GEL

ALCOHOL ANTISEPTIC 70%

enriched with aloe

CLEAN SCENT

TOPICAL SOLUTION

KILLS

GERMS &

BACTERIA

3.4OZ 100ML

NO-STERILE SOLUTION

Purpose

Antiseptic

Warnings

For external use only.

Flammable. Keep away from heat or flame

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F).
Active Ingredient(s)

Isopropyl Alcohol 70% v/v

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis (leaf) Extract, Fragrance, Glycerin, Purified Water

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:23.173851 · Updated: 2026-03-14T22:56:31.394385