ad4287fe-2b10-4a40-e053-2995a90a6340

SPL v3
SPL
SPL Set ID ad4287fe-2b10-4a40-e053-2995a90a6340
Route
topical
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (75 mL)
Inactive Ingredients
carbomer 940 water aloe vera leaf tea leaf oil rosemary oil

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-08-19
Purpose

Antiseptic

Description

Ethyl Alcohol 75% v/v

Medication Information

Warnings

For external use only. Flammable, keep away from fire or flame.

Purpose

Antiseptic

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

Aloe Barbadensis Leaf Extract, Aqua, Camellia Sinensis Leaf Oil, Carbomer, Rosmarinus Officinalis (Rosemary) Leaf Oil, Parfum.

Description

Ethyl Alcohol 75% v/v

Use

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

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50566-9

Irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Do Not Use
  • On children less than 2 months of age.
  • On open skin wounds.
Active Ingredient(s)

Ethyl Alcohol 75% v/v

Questions Or Comments?

Call 1-888-463-6332 Monday-Friday 9AM-5PM EST FDA NDC Product Code: 76741-003-12

Package Label Principal Display Panel

120 ml NDC:76741-003-12

Structured Label Content

Warnings

For external use only. Flammable, keep away from fire or flame.

Purpose

Antiseptic

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)

Aloe Barbadensis Leaf Extract, Aqua, Camellia Sinensis Leaf Oil, Carbomer, Rosmarinus Officinalis (Rosemary) Leaf Oil, Parfum.

Use

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

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50566-9 (50566-9)

Irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7 (50567-7)

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Do Not Use (Do not use)
  • On children less than 2 months of age.
  • On open skin wounds.
Active Ingredient(s)

Ethyl Alcohol 75% v/v

Questions Or Comments? (Questions or Comments?)

Call 1-888-463-6332 Monday-Friday 9AM-5PM EST FDA NDC Product Code: 76741-003-12

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

120 ml NDC:76741-003-12

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:13.190795 · Updated: 2026-03-14T22:59:07.764303