c92fd31c-4a21-4065-bfb2-f9e15c59c733

SPL v1
SPL
SPL Set ID c92fd31c-4a21-4065-bfb2-f9e15c59c733
Route
topical
Published
Effective Date 2020-05-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (75 mL)
Inactive Ingredients
water glycerin carbomer homopolymer, unspecified type .alpha.-tocopherol acetate

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-05-05

Description

Ethyl Alcohol 75%


Medication Information

Warnings

For external use only.

FLAMMABLE. Keep away from heat or flame.

When using this product

  • Avoid contact with eyes. If contact occurs, flush eyes with water.
  • Avoid contact with broken skin.

Stop use and consult doctor if irritation and redness develop and persist for more than 72 hours.

Indications and Usage

Directions
  • Wet hands with product and allow to dry without wiping.
  • For children under 6, use only under adult supervision.
  • Not recommended for infants.
Inactive Ingredients

Water (Eau), Glycerin, Carbomer, Fragrance (Parfum), Tocopheryl Acetate (Vitamin E).

Description

Ethyl Alcohol 75%

Section 50565-1

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Section 55105-1

Active Ingredient

Ethyl Alcohol 75%

Package Label Principal Display Panel

Label 60 mL

Label 100 mL

Label 300 mL

Label 500 mL


Structured Label Content

Warnings

For external use only.

FLAMMABLE. Keep away from heat or flame.

When using this product

  • Avoid contact with eyes. If contact occurs, flush eyes with water.
  • Avoid contact with broken skin.

Stop use and consult doctor if irritation and redness develop and persist for more than 72 hours.

Indications and Usage (34067-9)

Directions
  • Wet hands with product and allow to dry without wiping.
  • For children under 6, use only under adult supervision.
  • Not recommended for infants.
Inactive Ingredients (Inactive ingredients)

Water (Eau), Glycerin, Carbomer, Fragrance (Parfum), Tocopheryl Acetate (Vitamin E).

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Section 55105-1 (55105-1)

Active Ingredient

Ethyl Alcohol 75%

Package Label Principal Display Panel (Package Label - Principal Display Panel)

Label 60 mL

Label 100 mL

Label 300 mL

Label 500 mL


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)