Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 96ec1b3a-d79c-43b0-93a1-8c4367faed41
Route
TOPICAL
Published
Effective Date 2010-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
D&c Red No. 33 Fd&c Red No. 40 Glycerin Jojoba Oil Polyoxyl 40 Hydrogenated Castor Oil Propylene Glycol Alpha-tocopherol Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-09-01

Description

Ethyl Alcohol 62%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 62%

Uses
  • For handwashing to decrease bacteria on the skin
  • Recommended for repeated use
Warnings
  • For external use only
  • Flammable, keep away from fire and flame
  • Does not contain grain alcohol; do not drink, if taken internally will produce serious gastric disturbances
Directions
  • rub quarter sized amount between hands until dry
  • supervise children in the use of this product
  • in the case of eye contact, rinse eyes thoroughly with water

Package Label
Package Label





Active Ingredient

Ethyl Alcohol 62%

Other Information
  • store below 105F
  • may discolor some fabrics

Inactive Ingredients
Benzophenone-4, Carbomer, DC Red 33, FDC Red 40, Fragrance, Glycerin, Jojoba Oil, PEG-40 Hydrogenated Castor Oil, Propylene Glycol, Tocopherol, Triethanolamine, Water

When Using This Product
  • avoid the eyes an mucous membranes
  • in the case of eyes or mucous membrane contact; rinse area thoroughly with water

Stop Use and Ask A Doctor If
  • condition worsens
  • redness or irritation develops
  • if condition persists for more than 3 days

Keep Out of Reach of Children

If swallowed contact a doctor or Poison Control Center immediately.


Structured Label Content

Uses
  • For handwashing to decrease bacteria on the skin
  • Recommended for repeated use
Purpose

Antiseptic

Warnings
  • For external use only
  • Flammable, keep away from fire and flame
  • Does not contain grain alcohol; do not drink, if taken internally will produce serious gastric disturbances
Directions
  • rub quarter sized amount between hands until dry
  • supervise children in the use of this product
  • in the case of eye contact, rinse eyes thoroughly with water

Package Label
Package Label





Active Ingredient

Ethyl Alcohol 62%

Other Information (Other information)
  • store below 105F
  • may discolor some fabrics

Inactive Ingredients
Benzophenone-4, Carbomer, DC Red 33, FDC Red 40, Fragrance, Glycerin, Jojoba Oil, PEG-40 Hydrogenated Castor Oil, Propylene Glycol, Tocopherol, Triethanolamine, Water

When Using This Product (When using this product)
  • avoid the eyes an mucous membranes
  • in the case of eyes or mucous membrane contact; rinse area thoroughly with water

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • redness or irritation develops
  • if condition persists for more than 3 days

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

If swallowed contact a doctor or Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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