63148-402-03, 63148-402- Himark

63148-402-03, 63148-402- Himark
SPL v3
SPL
SPL Set ID f9643d82-ae87-ea72-e053-6394a90ad82f
Route
TOPICAL
Published
Effective Date 2023-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water Fragrance Clean Orc0600327 Acrylates/vinyl Isodecanoate Crosspolymer (10000 Mpa.s Neutralized At 0.5%) Aloe Vera Leaf Isopropyl Myristate Basic Blue 1 Glycerin Alpha-tocopherol Acetate Isopropyl Alcohol Basic Yellow 5 Polyethylene Glycol 300

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-01

Description

Ethyl Alcohol 70%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70%

Uses

For personal hand hygine to help prevent the spread of bacteria, and can be used in place of hand washing if soap and water are not available.

Warnings

For external use only.

  • Flammable
  • Keep away from source of heat or fire.
Questions

1-866-795-8481

Directions
  • For occasional and personal use.
  • Rub thoroughly into hands for at least 30 seconds. Allow to dry.
  • Children under 6 years should be supervised when using this product.
Do Not Use
  • On infants less than 2 months of age.
  • On open skin wounds
  • On broken or damaged skin.
Active Ingredient

Ethyl Alcohol 70%

Inactive Ingredients

Water (Aqua), PEG-6, AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, Fragrance (Parfum), Glycerin, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Isopropyl Alcohol, Isopropyl Myristate, Yellow 5 (Cl 19140), Blue 1 (Cl 42090).

Stop Use and Ask A Doctor

If irritation or redness develop and lasts.

Keep Out of Reach of Children

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

When Using This Product Avoid
  • Contact with eyes. If contact occurs, rinse eyes throughly with water.
  • Do not inhale.
Principal Display Panel 8 Fl Oz

Principal Display Panel 32 Fl Oz


Structured Label Content

Uses

For personal hand hygine to help prevent the spread of bacteria, and can be used in place of hand washing if soap and water are not available.

Purpose (PURPOSE)

Antiseptic

Warnings

For external use only.

  • Flammable
  • Keep away from source of heat or fire.
Questions

1-866-795-8481

Directions
  • For occasional and personal use.
  • Rub thoroughly into hands for at least 30 seconds. Allow to dry.
  • Children under 6 years should be supervised when using this product.
Do Not Use (Do not use)
  • On infants less than 2 months of age.
  • On open skin wounds
  • On broken or damaged skin.
Active Ingredient (ACTIVE INGREDIENT)

Ethyl Alcohol 70%

Inactive Ingredients

Water (Aqua), PEG-6, AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, Fragrance (Parfum), Glycerin, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Isopropyl Alcohol, Isopropyl Myristate, Yellow 5 (Cl 19140), Blue 1 (Cl 42090).

Stop Use and Ask A Doctor (Stop use and ask a doctor)

If irritation or redness develop and lasts.

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

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

When Using This Product Avoid (When using this product avoid)
  • Contact with eyes. If contact occurs, rinse eyes throughly with water.
  • Do not inhale.
Principal Display Panel 8 Fl Oz (Principal Display Panel 8 FL OZ)

Principal Display Panel 32 Fl Oz (Principal Display Panel 32 FL OZ)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)