Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 7e913872-f919-4da1-8897-e2d20190c368
Route
TOPICAL
Published
Effective Date 2013-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 g)
Inactive Ingredients
Water Glycerin Propylene Glycol Trolamine Aloe Vera Leaf Alpha-tocopherol Acetate Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-07-15

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 dime 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

Active Ingredient

Ethyl Alcohol 62%

Other Information
  • Store below 105F
  • May discolor some fabrics
Inactive Ingredients

Water (Aqua), Carbomer, Glycerin, Propylene Glycol, Triethanolamine, Aloe Barbadensis Leaf Gel, Tocopheryl Acetate, Fragrance (Parfum),  FDC Blue 1, FDC Yellow5

When Using This Product
  • Avoid the eyes and mucous membranes
  • In the case of eyes or mucous membrane contact; rinse area thoroughly with water Use only as directed
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 dime 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

Active Ingredient

Ethyl Alcohol 62%

Other Information (Other information)
  • Store below 105F
  • May discolor some fabrics
Inactive Ingredients

Water (Aqua), Carbomer, Glycerin, Propylene Glycol, Triethanolamine, Aloe Barbadensis Leaf Gel, Tocopheryl Acetate, Fragrance (Parfum),  FDC Blue 1, FDC Yellow5

When Using This Product (When using this product)
  • Avoid the eyes and mucous membranes
  • In the case of eyes or mucous membrane contact; rinse area thoroughly with water Use only as directed
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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