SPL v1
SPL
SPL Set ID aeef8836-ddfc-c810-e053-2a95a90a3598
Route
TOPICAL
Published
Effective Date 2020-04-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (122.4 g)
Inactive Ingredients
Water Glycerin Butylene Glycol Aloe Vera Leaf 1,2-hexanediol Hyaluronate Sodium Melaleuca Alternifolia Leaf Maltodextrin Green Tea Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-09
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, glycerin, butylene glycol, aloe barbadensis leaf extract, 1,2-hexanediol, sodium hyaluronate, melaleuca alternifolia (tea tree) leaf extract, maltodextrin, camellia sinensis leaf extract

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, glycerin, butylene glycol, aloe barbadensis leaf extract, 1,2-hexanediol, sodium hyaluronate, melaleuca alternifolia (tea tree) leaf extract, maltodextrin, camellia sinensis leaf extract

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: 2026-02-15T11:58:42.943843 · Updated: 2026-03-14T22:58:23.409829