SPL v1
SPL
SPL Set ID a79d6a56-52c7-0bd4-e053-2995a90a274c
Route
TOPICAL
Published
Effective Date 2020-04-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (350 mL)
Inactive Ingredients
Aloe Vera Leaf Grapefruit Edetate Disodium Anhydrous Water Polysorbate 20 Carbomer Homopolymer, Unspecified Type Isopropyl Myristate Aminomethylpropanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-01
Description

Alcohol

Medication Information

Warnings and Precautions

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 keep out of eyes, ears, and mouth. In case of contact with eyes, rinse 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.

Indications and Usage

wet hands thoroughly with product and allow to dry without wiping

for children under 6, use only under adult supervision

not recommended for infants

Dosage and Administration

for external use only

Description

Alcohol

Section 50565-1

keep out of reach of the children

Section 51727-6

water, carbomer, polysorbate 20, isopropyl myristate, aminomethyl propanol, disodium edta, grapefruit extract, aloe vera gel

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

Alcohol

Structured Label Content

Indications and Usage (34067-9)

wet hands thoroughly with product and allow to dry without wiping

for children under 6, use only under adult supervision

not recommended for infants

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

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 keep out of eyes, ears, and mouth. In case of contact with eyes, rinse 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.

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

water, carbomer, polysorbate 20, isopropyl myristate, aminomethyl propanol, disodium edta, grapefruit extract, aloe vera gel

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Alcohol

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:50.732525 · Updated: 2026-03-14T22:57:07.300794