SPL v1
SPL
SPL Set ID 44e04959-a21e-ba62-e063-6394a90a7192
Route
TOPICAL
Published
Effective Date 2026-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.7 mL)
Inactive Ingredients
Prunus Cerasus (bitter Cherry) Flower Extract Water Fragrance 13576 Butylene Glycol Hydroxyacetophenone

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-15

Description

Ethyl Alcohol 70% v/v--------Antibacterial


Medication Information

Warnings and Precautions

Warnings

For external use only.

Flammable, keep away from fire and flames

When using this product

test on a small area of skin before full use.

keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Avoid contact with broken skin.

Do not inhale or ingest.

Stop use and ask doctor if

allergy, irritation or redness develops. C

ondition persists for more than 72 hours.

Keep out of reach of children.

lf product is swallowed, get medical help or contact a poison control center right away.

Indications and Usage

Uses

For hand-washing to decrease bacteria on the skin.

Dosage and Administration

Directions

Spray hands with product and allow to dry without wiping.

For children under 6, use only under adult supervision.

Not recommended for infants.

Description

Ethyl Alcohol 70% v/v--------Antibacterial

Section 50565-1

If product is swallowed, get medical help or contact a poison control center right away.

Section 51727-6

Inactive ingredients:

WATER (AQUA), FRAGRANCE (PARFUM), PRUNUS CERASUS(BITTER CHERRY) EXTRACT, BUTYLENE GLYCOL, HYDROXYACETOPHENONE.

Section 51945-4

Section 53413-1

1-212-244-5170 [email protected]

Section 55105-1

Antibacterial

Section 55106-9

Ethyl Alcohol 70% v/v--------Antibacterial

Section 60561-8

Other information

Do not store above 105°F

May discolor some fabrics

Harmful to wood finishes and plastics


Structured Label Content

Indications and Usage (34067-9)

Uses

For hand-washing to decrease bacteria on the skin.

Dosage and Administration (34068-7)

Directions

Spray hands with product and allow to dry without wiping.

For children under 6, use only under adult supervision.

Not recommended for infants.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Flammable, keep away from fire and flames

When using this product

test on a small area of skin before full use.

keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Avoid contact with broken skin.

Do not inhale or ingest.

Stop use and ask doctor if

allergy, irritation or redness develops. C

ondition persists for more than 72 hours.

Keep out of reach of children.

lf product is swallowed, get medical help or contact a poison control center right away.

Section 50565-1 (50565-1)

If product is swallowed, get medical help or contact a poison control center right away.

Section 51727-6 (51727-6)

Inactive ingredients:

WATER (AQUA), FRAGRANCE (PARFUM), PRUNUS CERASUS(BITTER CHERRY) EXTRACT, BUTYLENE GLYCOL, HYDROXYACETOPHENONE.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-212-244-5170 [email protected]

Section 55105-1 (55105-1)

Antibacterial

Section 55106-9 (55106-9)

Ethyl Alcohol 70% v/v--------Antibacterial

Section 60561-8 (60561-8)

Other information

Do not store above 105°F

May discolor some fabrics

Harmful to wood finishes and plastics


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)