Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 1210276c-ec17-4c3c-89b8-8d76c7dbe94d
Route
TOPICAL
Published
Effective Date 2014-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 g)
Inactive Ingredients
Water Carbomer Interpolymer Type A (55000 Cps) Trolamine Polyoxyl 40 Hydrogenated Castor Oil Hydrolyzed Jojoba Esters (acid Form) Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-09-01

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 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), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Fragrance (Parfum), PEG-40 Hydrogenated Castor Oil, Jojoba Esters, Yellow 5

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), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Fragrance (Parfum), PEG-40 Hydrogenated Castor Oil, Jojoba Esters, Yellow 5

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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