drug fact

drug fact
SPL v1
SPL
SPL Set ID 9a7f882d-3859-4711-8f8c-1126a6b1b514
Route
topical
Published
Effective Date 2020-07-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (75 mL)
Inactive Ingredients
glycerin propylene glycol water trolamine edetate disodium carbomer copolymer type a aminomethylpropanol .alpha.-tocopherol acetate, d- denatonium benzoate

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-07-10

Purpose

Antiseptic

Description

Ethyl Alcohol 75%


Medication Information

Warnings

For external use only.

Flammable, keep from fire or flame.

Avoid contact with broken skin.

When using this product  do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rah appears and lasts.

Other information

  • Do not store above 110℉
  • May discolor some fabrics.
Uses
  • Apply topically as needed to cleanse
Purpose

Antiseptic

Directions
  • Wet hands thoroughly with product and allow to dry without wiping.
  • Children under 6 years of age should be supervised when using this product.
  • Not recomended for infants.
Inactive Ingredients

Water (Aqua), Glycerin, Propylene Glycol, Acrylates/C10-30Alkyl Acrylate Crosspolymer, Ainomethyl Propanol, Fragrance (Parfum), Denatonium Benzoate, Tocopheryl Actate, Aloe Barbadensis Leaf Juice, Maltodextrin.

Description

Ethyl Alcohol 75%

Product Labeling

Active Ingredient

Ethyl Alcohol 75%

Keep Out of Reach of Children.

If swallowed, get medical help.


Structured Label Content

Warnings

For external use only.

Flammable, keep from fire or flame.

Avoid contact with broken skin.

When using this product  do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rah appears and lasts.

Other information

  • Do not store above 110℉
  • May discolor some fabrics.
Uses
  • Apply topically as needed to cleanse
Purpose

Antiseptic

Directions
  • Wet hands thoroughly with product and allow to dry without wiping.
  • Children under 6 years of age should be supervised when using this product.
  • Not recomended for infants.
Inactive Ingredients

Water (Aqua), Glycerin, Propylene Glycol, Acrylates/C10-30Alkyl Acrylate Crosspolymer, Ainomethyl Propanol, Fragrance (Parfum), Denatonium Benzoate, Tocopheryl Actate, Aloe Barbadensis Leaf Juice, Maltodextrin.

Product Labeling

Active Ingredient

Ethyl Alcohol 75%

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

If swallowed, get medical help.


Advanced Ingredient Data


Raw Label Data

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