SPL v3
SPL
SPL Set ID 2143884b-08d5-46ae-bd99-6d04a7165d89
Route
TOPICAL
Published
Effective Date 2013-07-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Triclosan (10 mg)
Inactive Ingredients
Ceteth-7 Ethyl Sulfate Coconut Oil Diethanolamine Citric Acid Monohydrate Octhilinone Water Sodium Chloride Edetate Disodium Fd&c Yellow No. 5 Fd&c Red No. 40

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-07-05
Description

Active Ingredient                  Purpose Triclosan 0.2%......................Antiseptic

Medication Information

Warnings and Precautions

Warnings:

for external use only.

Flammable. Keep away from heat and flame.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Indications and Usage

USE: 

  • handwashing to decrease bacteria on the skin
Dosage and Administration

Directions:

  • wet hands thoroughly with product
  • briskly rub hands together until dry
  • supervise children in the use of this product
Description

Active Ingredient                  Purpose Triclosan 0.2%......................Antiseptic

Section 50565-1

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients:

aloe vera leaf juice, carbomer, glycerin, propylene glycol, tocopheryl acetate (vitamin E), triethanolamine, water.

Section 51945-4

Section 55105-1

Health Care Instant Hand Sanitizer - Ice Clear - Extra Enriched with Vitamin E Bead & Aloe

Kills 99.9% of Germs without water or towels!

Section 55106-9

Active Ingredient                  Purpose

Triclosan 0.2%......................Antiseptic

Structured Label Content

Indications and Usage (34067-9)

USE: 

  • handwashing to decrease bacteria on the skin
Dosage and Administration (34068-7)

Directions:

  • wet hands thoroughly with product
  • briskly rub hands together until dry
  • supervise children in the use of this product
Warnings and Precautions (34071-1)

Warnings:

for external use only.

Flammable. Keep away from heat and flame.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Section 50565-1 (50565-1)

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients:

aloe vera leaf juice, carbomer, glycerin, propylene glycol, tocopheryl acetate (vitamin E), triethanolamine, water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Health Care Instant Hand Sanitizer - Ice Clear - Extra Enriched with Vitamin E Bead & Aloe

Kills 99.9% of Germs without water or towels!

Section 55106-9 (55106-9)

Active Ingredient                  Purpose

Triclosan 0.2%......................Antiseptic

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:22.871448 · Updated: 2026-03-14T23:00:47.249871