SPL v1
SPL
SPL Set ID 3293c5a7-d39b-4f4e-e063-6394a90abf9a
Route
TOPICAL
Published
Effective Date 2025-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (71 mL)
Inactive Ingredients
Water Glycereth-26 Butylene Glycol D&c Red No. 33 Dipropylene Glycol Fd&c Red No. 4 Fd&c Blue No. 1 Leuconostoc/radish Root Ferment Filtrate Aloe Barbadensis Leaf Juice Glycerin Phenoxyethanol Fd&c Yellow No. 5 Fd&c Red No. 40

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-01

Description

ETHYL ALCOHOL 70%

Purpose

ANTISEPTIC


Medication Information

Purpose

ANTISEPTIC

Description

ETHYL ALCOHOL 70%

Use

To decrease bacteria on the skin that could cause disease.

Recommended for repeated use.

Section 50565-1

Keep out of reach of children. In case of ingestion, seek

medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if skin irritation develops.

Section 50567-7

none

Section 51945-4

Warning

For external use only. Flammable. keep away from fire or flame

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 a doctor if skin irritation develops.

Keep out of reach of children.In case of ingestion, seek

medical help or contact a Poison Control Center right away.

Directions

Spary product in your palm and rub hands together until dry.

For children under 6, use only under adult supervision

Not recommended for infants

Active Ingredient

ETHYL ALCOHOL 70%

Other Information

Do not store above 105'F,

May discolor some fabrics

Harmful to wood finishes and plastics,

Inactive Ingredients

Water, Glycerin, Dipropylene Glycol, Glycereth-26,Fragrance, Butylene Glycol, Leuconostoc Radish RootFerment Filtrate, Aloe Barbadensis Leaf Juice,Phenoxyethanol. May Contain: Red 4 Lake(Cl 14700),Yellow 5 Lake(Cl19140),Red 33 Lake(C117200),Blue 1(Cl 42090)


Structured Label Content

Use (USE)

To decrease bacteria on the skin that could cause disease.

Recommended for repeated use.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of ingestion, seek

medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if skin irritation develops.

Section 50567-7 (50567-7)

none

Section 51945-4 (51945-4)

Purpose

ANTISEPTIC

Warning

For external use only. Flammable. keep away from fire or flame

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 a doctor if skin irritation develops.

Keep out of reach of children.In case of ingestion, seek

medical help or contact a Poison Control Center right away.

Directions

Spary product in your palm and rub hands together until dry.

For children under 6, use only under adult supervision

Not recommended for infants

Active Ingredient (Active ingredient)

ETHYL ALCOHOL 70%

Other Information (Other information)

Do not store above 105'F,

May discolor some fabrics

Harmful to wood finishes and plastics,

Inactive Ingredients

Water, Glycerin, Dipropylene Glycol, Glycereth-26,Fragrance, Butylene Glycol, Leuconostoc Radish RootFerment Filtrate, Aloe Barbadensis Leaf Juice,Phenoxyethanol. May Contain: Red 4 Lake(Cl 14700),Yellow 5 Lake(Cl19140),Red 33 Lake(C117200),Blue 1(Cl 42090)


Advanced Ingredient Data


Raw Label Data

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