a61ab277-457c-1517-e053-2995a90ae7a8

SPL v3
SPL
SPL Set ID a61ab277-457c-1517-e053-2995a90ae7a8
Route
topical
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
isopropyl alcohol (75 mL)
Inactive Ingredients
glycerin hydrogen peroxide water carbomer 1342 fd&c yellow no. 5 .alpha.-tocopherol acetate aloe vera leaf fd&c blue no. 1

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-05-20
Purpose

Antiseptic, Hand Sanitizer

Description

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. The hand sanitizer is manufactured using only the following ingredients in the preparation of the product: Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Sterile distilled water or boiled cold water. Hydrogen Peroxide Glycerin Carbomer 1342 Aloe Vera Leaf FD&C Blue No. 1 FD&C Yellow No. 5 Alpha Tocopherol Acetate Fragrance The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Medication Information

Warnings

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

Purpose

Antiseptic, Hand Sanitizer

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)
Inactive Ingredients

Water, Hydrogen Peroxide, Glycerin, Carbomer 1342, Aloe Vera Leaf, FD&C Blue No. 1, FD&C Yellow No. 5, Alpha Tocopherol Acetate, Fragrance.

Description

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. The hand sanitizer is manufactured using only the following ingredients in the preparation of the product: Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Sterile distilled water or boiled cold water. Hydrogen Peroxide Glycerin Carbomer 1342 Aloe Vera Leaf FD&C Blue No. 1 FD&C Yellow No. 5 Alpha Tocopherol Acetate Fragrance The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 42229-5

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

The hand sanitizer is manufactured using only the following ingredients in the preparation of the product:

Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

Sterile distilled water or boiled cold water.

Hydrogen Peroxide

Glycerin

Carbomer 1342

Aloe Vera Leaf

FD&C Blue No. 1

FD&C Yellow No. 5

Alpha Tocopherol Acetate

Fragrance

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

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 or rash 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 or rash 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.

Do Not Use
  • In children less than 2 months of age
  • On open skin wounds
  • In eyes. In case of contact, rinse eyes thoroughly with water
Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Package Label Principal Display Panel

59 mL NDC: 74988-760-20

118 mL NDC: 74988-760-40

236 mL NDC: 74988-760-80

473 mL NDC: 74988-760-16

3.79 L NDC: 74988-760-37

208 L NDC: 74988-760-55

1041 L NDC: 74988-760-41

25741 L NDC: 74988-760-74

Structured Label Content

Warnings

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

Purpose

Antiseptic, Hand Sanitizer

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)
Inactive Ingredients (Inactive ingredients)

Water, Hydrogen Peroxide, Glycerin, Carbomer 1342, Aloe Vera Leaf, FD&C Blue No. 1, FD&C Yellow No. 5, Alpha Tocopherol Acetate, Fragrance.

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 42229-5 (42229-5)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

The hand sanitizer is manufactured using only the following ingredients in the preparation of the product:

Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

Sterile distilled water or boiled cold water.

Hydrogen Peroxide

Glycerin

Carbomer 1342

Aloe Vera Leaf

FD&C Blue No. 1

FD&C Yellow No. 5

Alpha Tocopherol Acetate

Fragrance

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

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 or rash 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 or rash 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.

Do Not Use (Do not use)
  • In children less than 2 months of age
  • On open skin wounds
  • In eyes. In case of contact, rinse eyes thoroughly with water
Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

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

59 mL NDC: 74988-760-20

118 mL NDC: 74988-760-40

236 mL NDC: 74988-760-80

473 mL NDC: 74988-760-16

3.79 L NDC: 74988-760-37

208 L NDC: 74988-760-55

1041 L NDC: 74988-760-41

25741 L NDC: 74988-760-74

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:57:57.149068 · Updated: 2026-03-14T22:57:15.604123