Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 5a666543-bedf-4301-a9bd-92d92f3cae4a
Route
TOPICAL
Published
Effective Date 2012-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Triclosan (0.3 g)
Inactive Ingredients
Benzophenone Citric Acid Monohydrate Cocamidopropyl Betaine Coco Diethanolamide Edetate Disodium Fd&c Blue No. 1 Fd&c Yellow No. 5 Methylchloroisothiazolinone Methylisothiazolinone Peg-150 Distearate Sodium Laureth Sulfate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-10-21
Description

Triclosan 0.3%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Triclosan 0.3%

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
  • Wet hands, work into a lather. Rinse well
  • Supervise children in the use of this product
  • In the case of eye contact, rinse eyes thoroughly with water
Package Label

Active Ingredient

Triclosan 0.3%

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

Benzophenone-4, Citric Acid, Cocamidopropyl Betaine, Cocamide DEA, Disodium EDTA, FDC Blue 1, FDC Yellow 5, Fragrance (Parfum), Methylchloroisothiazolinone, Methylisothiazolinone, PEG-150 Distearate, Sodium Laureth Sulfate, Water (Aqua)

When Using This Product
  • Avoid the eyes and mucous membranes
  • In the case of eye or mucous membrane contact; rinse area thoroughly with water
Stop Use and Ask A Doctor If
  • condition worsens
  • redness or irritation develops
  • 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
  • Wet hands, work into a lather. Rinse well
  • Supervise children in the use of this product
  • In the case of eye contact, rinse eyes thoroughly with water
Package Label

Active Ingredient

Triclosan 0.3%

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

Benzophenone-4, Citric Acid, Cocamidopropyl Betaine, Cocamide DEA, Disodium EDTA, FDC Blue 1, FDC Yellow 5, Fragrance (Parfum), Methylchloroisothiazolinone, Methylisothiazolinone, PEG-150 Distearate, Sodium Laureth Sulfate, Water (Aqua)

When Using This Product (When using this product)
  • Avoid the eyes and mucous membranes
  • In the case of eye 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
  • 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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:32.040832 · Updated: 2026-03-14T22:53:17.603568