SPL v2
SPL
SPL Set ID a9d6d768-a38d-7e5e-e053-2995a90a5aad
Route
TOPICAL
Published
Effective Date 2020-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Glycerin Aloe Water Trolamine 1,2-propanediol, 1-benzoate .alpha.-tocopherol Acetate Carbomer Homopolymer, Unspecified Type

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-07

Description

Ethyl Alcohol 70%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70%

Uses
  • hand sanitizer to help decrease bacteria on the skin
  • when water, soap & towel are not available.
  • recommended for repeated use
Section 51945-4

Warnings

For external use only. Flammable. Keep away from fire or flame.

Directions
  • pump as needed into your palms and thoroughly spread on both hands
  • rub into skin until dry.
Do Not Use

Do not apply around eyes. Do not use in ears & mouth.

Active Ingredient

Ethyl Alcohol 70%

Other Information
  • store at 20 C (68 to77 F)
  • may discolor fabrics
Inactive Ingredients

Water,

Triethanolamine,

Carbomer,

Aloe Barbadensis Gel

Fragrance,

Glycerin,

Propylene Glycol,

Tocopheryl Acetate (Vitamine E)

When Using This Product

When using this product, avoid contact with eyes. In case of contact flush eyes with water.

Stop Use and Ask A Doctor If

Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

Keep Out of Reach of Children

Children must be supervised in use of this product.


Structured Label Content

Uses
  • hand sanitizer to help decrease bacteria on the skin
  • when water, soap & towel are not available.
  • recommended for repeated use
Section 51945-4 (51945-4)

Purpose

Antiseptic

Warnings

For external use only. Flammable. Keep away from fire or flame.

Directions
  • pump as needed into your palms and thoroughly spread on both hands
  • rub into skin until dry.
Do Not Use (Do not use)

Do not apply around eyes. Do not use in ears & mouth.

Active Ingredient (Active ingredient)

Ethyl Alcohol 70%

Other Information (Other information)
  • store at 20 C (68 to77 F)
  • may discolor fabrics
Inactive Ingredients (Inactive ingredients)

Water,

Triethanolamine,

Carbomer,

Aloe Barbadensis Gel

Fragrance,

Glycerin,

Propylene Glycol,

Tocopheryl Acetate (Vitamine E)

When Using This Product (When using this product)

When using this product, avoid contact with eyes. In case of contact flush eyes with water.

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

Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

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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