Ndc- 63148-502, Guard Hand Sanitizer

Ndc- 63148-502, Guard Hand Sanitizer
SPL v3
SPL
SPL Set ID fdc99948-1bd0-cdf2-e053-6394a90aaf97
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
Acrylates/vinyl Isodecanoate Crosspolymer (10000 Mpa.s Neutralized At 0.5%) Polyethylene Glycol 300 Glycerin Water Isopropyl Myristate Isopropyl Alcohol Aloe Vera Leaf Fragrance Clean Orc0600327 .alpha.-tocopherol Acetate

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.
Directions
  • For occassional and Personal use.
  • Rub thoroughly into hands for at least 30 seconds. Allo 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.
Package Label

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.

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 Poison Control Center immediately.

When Using This Product Avoid
  • contact with eyes. If contact occurs, rinse eyes thoroughly with water.
  • Do not inhale.

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

Antiseptic

Warnings

For external use only.

  • Flammable
  • Keep away from source of heat or fire.
Directions
  • For occassional and Personal use.
  • Rub thoroughly into hands for at least 30 seconds. Allo 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.
Package Label

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.

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 Poison Control Center immediately.

When Using This Product Avoid (When using this product avoid)
  • contact with eyes. If contact occurs, rinse eyes thoroughly with water.
  • Do not inhale.

Advanced Ingredient Data


Raw Label Data

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