af489ea1-14c0-33f0-e053-2995a90abdd1

SPL v3
SPL
SPL Set ID af489ea1-14c0-33f0-e053-2995a90abdd1
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 rosemary oil aloe vera leaf tea leaf oil

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-09-14
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: 76741-005-12
Package Label Principal Display Panel

120 ml NDC: 76741-005-12

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: 76741-005-12
Package Label Principal Display Panel (Package Label - Principal Display Panel)

120 ml NDC: 76741-005-12

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:13.191824 · Updated: 2026-03-14T22:59:07.764303