SPL v2
SPL
SPL Set ID aeeaeecf-d2a7-0934-e053-2a95a90a1a41
Route
TOPICAL
Published
Effective Date 2020-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (50.967 g)
Inactive Ingredients
Green Tea Leaf Water Glycerin Calendula Officinalis Flower

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

plae enough product on hands to cover all surfaces, rub hands together until dry

Dosage and Administration

for external use only

Description

alcohol

Section 50565-1

keep out of reach of the children

Section 51727-6

Water

Glycerin

Camellia Sinensis Leaf Extract

calendula officinalis flower extract

Section 51945-4

Section 55105-1

hand sanitizing tissue to help reduce bacteria on the skin

Section 55106-9

alcohol

Structured Label Content

Indications and Usage (34067-9)

plae enough product on hands to cover all surfaces, rub hands together until dry

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

Camellia Sinensis Leaf Extract

calendula officinalis flower extract

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

hand sanitizing tissue to help reduce bacteria on the skin

Section 55106-9 (55106-9)

alcohol

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:50.747637 · Updated: 2026-03-14T22:58:38.353182