Ndc- 63148-725

Ndc- 63148-725
SPL v2
SPL
SPL Set ID a259d254-52ae-4612-aa9e-a36480ad151a
Route
TOPICAL
Published
Effective Date 2021-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (700 mg)
Inactive Ingredients
Water Polyethylene Glycol 300 Acrylates/vinyl Isodecanoate Crosspolymer (10000 Mpa.s Neutralized At 0.5%) Fragrance Clean Orc0600327 Isopropyl Myristate Glycerin Isopropyl Alcohol .alpha.-tocopherol Acetate, Dl- Aloe Vera Leaf Direct Yellow 6 Basic Blue 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-08

Description

Ethyl Alcohol (70%)

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol (70%)

Uses

For Personal hand hygiene to help prevent the spread of bacteria. 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. 
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 children less than 2 months of age
  • on open skin wounds
  • on broken or damaged skin
Other Information
  • Store at a temperature below 110 0F (43 0C)
  • May discolor certain fabrics or surfaces
Active Ingredients

Ethyl Alcohol (70%)

Inactive Ingredients

Water (Aqua), PEG-6, AMP-Acrylates/Vinyl Isodecanate Crosspolymer, Fragrance (Parfum), Isopropyl Myristate, Glycerin, Isopropyl Alcohol, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Yellow 6 (Cl15985), Blue 1 (Cl42090)

Principal Display Panel

When Using This Product

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Do not Inhale.

Stop Use and Ask A Doctor

If Irritation or redness develops and lasts.

Keep Out of Reach of Children

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


Structured Label Content

Uses

For Personal hand hygiene to help prevent the spread of bacteria. Can be used in place of hand washing if soap and water are not available.

Purpose

Antiseptic

Warnings
  • For External use only
  • Flammable
  • Keep away from source of heat or fire. 
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 children less than 2 months of age
  • on open skin wounds
  • on broken or damaged skin
Other Information
  • Store at a temperature below 110 0F (43 0C)
  • May discolor certain fabrics or surfaces
Active Ingredients

Ethyl Alcohol (70%)

Inactive Ingredients

Water (Aqua), PEG-6, AMP-Acrylates/Vinyl Isodecanate Crosspolymer, Fragrance (Parfum), Isopropyl Myristate, Glycerin, Isopropyl Alcohol, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Yellow 6 (Cl15985), Blue 1 (Cl42090)

Principal Display Panel

When Using This Product (When using this product)

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Do not Inhale.

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

If Irritation or redness develops 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 Centre immediately


Advanced Ingredient Data


Raw Label Data

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