e56490e5-cef7-734f-e053-2995a90a15fc

SPL v2
SPL
SPL Set ID e56490e5-cef7-734f-e053-2995a90a15fc
Route
topical
Published
Effective Date 2022-08-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (83 mL)
Inactive Ingredients
water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2022-05-01

Description

ethanol


Medication Information

Warnings and Precautions

For external use only

  • If taken internally, serious gastric disturbances will result
  • flammable, keep away from heat or flame

Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns

When using this product

  • do not use in or near eyes. In case of contact with eyes, rinse eyes thoroughly with water
  • do not apply over large areas of the body
  • do not use longer than one week unless directed by a doctor

Stop use and ask a doctor if irritation or rash appears

Keep out of reach of children. In case of ingestion, get medical help or contact a Poison Control Center 1-800-222-1222 or dial 911 immediately

Active Ingredient

ethanol

Indications and Usage

For the external use only

Dosage and Administration

Clean affected area

Apply small amount of this product on the affected area 1-3 times daily

May be covered with a sterile bandage. If bandaged, let dry first

children under 6 years of age should be supervised when using this product

Description

ethanol

Section 50565-1

Keep out of reach of children

Section 51727-6

Water

Section 51945-4

Section 55105-1

First aid to help prevent the risk of infection in minor cuts, scrapes or burns.


Structured Label Content

Warnings and Precautions (34071-1)

For external use only

  • If taken internally, serious gastric disturbances will result
  • flammable, keep away from heat or flame

Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns

When using this product

  • do not use in or near eyes. In case of contact with eyes, rinse eyes thoroughly with water
  • do not apply over large areas of the body
  • do not use longer than one week unless directed by a doctor

Stop use and ask a doctor if irritation or rash appears

Keep out of reach of children. In case of ingestion, get medical help or contact a Poison Control Center 1-800-222-1222 or dial 911 immediately

Active Ingredient (55106-9)

ethanol

Indications and Usage (34067-9)

For the external use only

Dosage and Administration (34068-7)

Clean affected area

Apply small amount of this product on the affected area 1-3 times daily

May be covered with a sterile bandage. If bandaged, let dry first

children under 6 years of age should be supervised when using this product

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

First aid to help prevent the risk of infection in minor cuts, scrapes or burns.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)