Drug Fact

Drug Fact
SPL v1
SPL
SPL Set ID d34e9cc1-ea17-4089-be62-6173d6b976a4
Route
TOPICAL
Published
Effective Date 2020-06-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Glycerin Carbomer 934 Water Trolamine Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-22

Description

Ethyl Alcohol 62%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 62%

Uses
  • decrease bacteria and germs on the hands
  • use when soap , towel and water are not available.
  • recommended for repeared use.
Section 50567-7

avoid contact with eyes. In case of contact flush eyes with water

Warnings

For external use only.

S top use and ask a doctor if irritation or redness develops or persists.

Flammable,  keep away from fire or flame

Do not apply around eyes.

Do not use in ears and mouth

Other information:

  • store at 20℃ (68 to 77 ℉)
  • may discolor fabrics
Directions

No water needed. Apply a small amount of product to dry skin. Rub briskly. wipe with paper towel or clean cloth or rinse with water and dry.

Product Labeling

Active Ingredient

Ethyl Alcohol 62%

Consult A Physicia

if irritation or redness develops or persists

Inactive Ingredients

Aloe vera Gel, Extracts of juniper, Eucalyptus oil, Thymol, Essence (Radlx), Carbomer, Diisopropanol amine, Purified water

Keep Out of Reach of Children.

 Children under 6, use only under adult supervision. Not recommended for infants.


Structured Label Content

Uses
  • decrease bacteria and germs on the hands
  • use when soap , towel and water are not available.
  • recommended for repeared use.
Section 50567-7 (50567-7)

avoid contact with eyes. In case of contact flush eyes with water

Purpose

Antiseptic

Warnings

For external use only.

S top use and ask a doctor if irritation or redness develops or persists.

Flammable,  keep away from fire or flame

Do not apply around eyes.

Do not use in ears and mouth

Other information:

  • store at 20℃ (68 to 77 ℉)
  • may discolor fabrics
Directions

No water needed. Apply a small amount of product to dry skin. Rub briskly. wipe with paper towel or clean cloth or rinse with water and dry.

Product Labeling

Active Ingredient

Ethyl Alcohol 62%

Consult A Physicia (consult a physicia)

if irritation or redness develops or persists

Inactive Ingredients

Aloe vera Gel, Extracts of juniper, Eucalyptus oil, Thymol, Essence (Radlx), Carbomer, Diisopropanol amine, Purified water

Keep Out of Reach of Children. (Keep out of reach of children.)

 Children under 6, use only under adult supervision. Not recommended for infants.


Advanced Ingredient Data


Raw Label Data

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