adebaadf-8a7c-1a51-e053-2995a90a381a

SPL v1
SPL
SPL Set ID adebaadf-8a7c-1a51-e053-2995a90a381a
Route
topical
Published
Effective Date 2020-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (75 mL)
Inactive Ingredients
glycerin trolamine carbomer homopolymer, unspecified type water aloe .alpha.-tocopherol acetate

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-08-28

Purpose

Antiseptic

Description

Ethyl alcohol 75% v/v


Medication Information

Warnings

For external use only.

Flammable, keep away from heat and flame.

Purpose

Antiseptic

Directions
  • Put enough product in your palm to cover hands and rub hands together until dry.
  • Children under 6 years of age should be supervised when using this product.
Other Information
  • Store below 110F (43C)
  • May discolor certian fabrics or surfaces.
Inactive Ingredients

Aqua(Water),

Glycerin,

Carbomer,

Triethanolamine,

Fragrance,

Aloe,

Tocopheryl Acetate (Vitamin E)

Description

Ethyl alcohol 75% v/v

Use
  • For hand washing to decrease bacteria on the skin.
  • Recommended for repeated use.
Label

Do Not Use

Do not use in the eyes, in case of contact, rinse eyes thoroughly with water.

Do not use on children less than 2 months of age.

Active Ingredient

Ethyl alcohol 75% v/v

Stop Use and Ask A Doctor If
  • Irritation and redness develop and persist for more than 72 hours.
  • Swallowed, get medical help or contact a posion control center right away.
Keep Out of Reach of Children

Children must be supervised in use of this product.


Structured Label Content

Warnings

For external use only.

Flammable, keep away from heat and flame.

Purpose

Antiseptic

Directions
  • Put enough product in your palm to cover hands and rub hands together until dry.
  • Children under 6 years of age should be supervised when using this product.
Other Information (Other information)
  • Store below 110F (43C)
  • May discolor certian fabrics or surfaces.
Inactive Ingredients (Inactive ingredients)

Aqua(Water),

Glycerin,

Carbomer,

Triethanolamine,

Fragrance,

Aloe,

Tocopheryl Acetate (Vitamin E)

Use
  • For hand washing to decrease bacteria on the skin.
  • Recommended for repeated use.
Label

Do Not Use (Do not use)

Do not use in the eyes, in case of contact, rinse eyes thoroughly with water.

Do not use on children less than 2 months of age.

Active Ingredient (Active ingredient)

Ethyl alcohol 75% v/v

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Irritation and redness develop and persist for more than 72 hours.
  • Swallowed, get medical help or contact a posion control center right away.
Keep Out of Reach of Children (Keep out of reach of children)

Children must be supervised in use of this product.


Advanced Ingredient Data


Raw Label Data

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