Drug Fact

Drug Fact
SPL v1
SPL
SPL Set ID 9827418a-3ab6-447b-8f8a-9eacb56d3a89
Route
TOPICAL
Published
Effective Date 2017-10-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Aloe Vera Leaf Glycerin Eucalyptus Oil Tocopherol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-10-09

Description

Ethyl Alcohol  62%

Purpose

antiseptic


Medication Information

Purpose

antiseptic

Description

Ethyl Alcohol  62%

Uses
  • to decrease bacteria on the skin that could cause disease
  • recommended for repeated use

Warnings

For external use only- hands.

Flammable. Keep away from heat and flame.

When using this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Avoid contact with broken skin.

Do not inhale or ingest.

Stop use and ask a doctor if skin irritation develops.

Directions
  • wet hands thoroughly with product and allow to dry without wiping
  • for children under 6, use only under adult supervision
  • not recommended for infants
Product Labeling

Active Ingredient

Ethyl Alcohol  62%

Other Information
  • do not store above 105 F.
  • may discolor some babrics
  • harmful to wood finishes and plastics
Inactive Ingredients

alcohol, aloe vere gel, extracts of juniper, eucalyptus oil, carbomer, thymol essence (radix), diisoprpanol amine, purified water.

When Using This Product
  • keep out of eyes. In case of contact with eyes, immediately flush with water and call a doctor.
  • avoid contact with broken skin.

Stop Use and Ask A Doctor

if skin irritation develops

Keep Out of Reach of Children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.


Structured Label Content

Uses
  • to decrease bacteria on the skin that could cause disease
  • recommended for repeated use

Purpose

antiseptic

Warnings

For external use only- hands.

Flammable. Keep away from heat and flame.

When using this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Avoid contact with broken skin.

Do not inhale or ingest.

Stop use and ask a doctor if skin irritation develops.

Directions
  • wet hands thoroughly with product and allow to dry without wiping
  • for children under 6, use only under adult supervision
  • not recommended for infants
Product Labeling

Active Ingredient

Ethyl Alcohol  62%

Other Information
  • do not store above 105 F.
  • may discolor some babrics
  • harmful to wood finishes and plastics
Inactive Ingredients

alcohol, aloe vere gel, extracts of juniper, eucalyptus oil, carbomer, thymol essence (radix), diisoprpanol amine, purified water.

When Using This Product (When using this product)
  • keep out of eyes. In case of contact with eyes, immediately flush with water and call a doctor.
  • avoid contact with broken skin.

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

if skin irritation develops

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

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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