SPL v1
SPL
SPL Set ID a92ede70-7dc4-2a31-e053-2995a90aa5f3
Route
TOPICAL
Published
Effective Date 2020-06-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Trolamine Glycerin Propylene Glycol Aloe Water Carbomer Homopolymer, Unspecified Type .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-29

Description

Ethyl Alcohol 62%

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

Ethyl Alcohol 62%

Uses
  • helps reduce bacteria on the skin that could cause disease.
  • Recommended for repeated use
Label

Section 55106-9

Ethyl Alcohol 62%

Warnings

For external use only

Flammable

Keep away from fire or flame

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

Water

Aloe Barbadensis Gel

Carbomer

Glycerin

Triethanoloamine

Tocopheryl Acetate

When Using This Product

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

Stop Use and Ask A Doctor If

Stop use and ask a doctor if irritation and redness develops and lasts more than 72 hours.

Keep Out of Reach of Children

if swallowed, get medical help or contact a Posion Control Center right away.


Structured Label Content

Uses
  • helps reduce bacteria on the skin that could cause disease.
  • Recommended for repeated use
Label

Section 55106-9 (55106-9)

Ethyl Alcohol 62%

Purpose

Antimicrobial

Warnings

For external use only

Flammable

Keep away from fire or flame

Directions
  • Place enough product in your palm to thoroughly cover your hands
  • Rub hands together briskly 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 certain fabrics or surfaces
Inactive Ingredients (Inactive ingredients)

Water

Aloe Barbadensis Gel

Carbomer

Glycerin

Triethanoloamine

Tocopheryl Acetate

When Using This Product (When using this product)

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

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

Stop use and ask a doctor if irritation and redness develops and lasts more than 72 hours.

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

if swallowed, get medical help or contact a Posion Control Center right away.


Advanced Ingredient Data


Raw Label Data

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