Drug Facts Box - Back Panel

Drug Facts Box - Back Panel
SPL v1
SPL
SPL Set ID 8abc1ead-3e4e-4e5a-8e59-8f043bb20bb9
Route
TOPICAL
Published
Effective Date 2010-08-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Triclosan (0.3000 mL)

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-08-24

Description

Triclosan 0.3%

Purpose

Antibacterial


Medication Information

Purpose
Antibacterial



Description

Triclosan 0.3%

Uses

For washing to decrease bacteria on the skin.

Warnings

For external use only.

Directions

Apply onto wet hands, work into a lather. Rinse thoroughly.

Active Ingredient

Triclosan 0.3%

Inactive Ingredients

Water (Aqua), Sodium Laureth Sulfate, Acrylates Copolymer, Cocamidopropyl Betaine, Cocamide DEA, Sodium Chloride, Fragrance (Parfum), Aloe Barbadensis Leaf Juice, PEG-7 Glyceryl Cocoate, Helianthus Annuus (Sunflower) Seed Extract, Tetrasodium EDTA, Sodium Styrene/PEG-10 Maleate/Nonoxynol-10 Maleate/ Acrylates Copolymer, Ammonium Nonoxynol-4 Sulfate, Citric Acid, Sodium Hydroxide, Mannitol, Cellulose, Tocopheryl Acetate, Hydroxypropyl Methylcellulose, Mica, Titanium Oxide (CI 77891), Yellow 10 (CI 47005), Red 40 (CI 16035), Iron Oxides ( CI 77492), Methylchloroisothiazolinone, Methylisothiazolinone.

When Using This Product

- Avoid contact with eyes. If contact occurs, rinse with water.

Keep Out of Reach of Children

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Package Front and Back Labels
  • 8.5 OZ Front Panel Label: eobf.jpg
  • 8.5 OZ Back Panel Label: eobb.jpg
Stop Using This Product and Ask Doctor If
- Irritation or redness develops and lasts.


Structured Label Content

Uses

For washing to decrease bacteria on the skin.

Purpose
Antibacterial



Warnings

For external use only.

Directions

Apply onto wet hands, work into a lather. Rinse thoroughly.

Active Ingredient

Triclosan 0.3%

Inactive Ingredients

Water (Aqua), Sodium Laureth Sulfate, Acrylates Copolymer, Cocamidopropyl Betaine, Cocamide DEA, Sodium Chloride, Fragrance (Parfum), Aloe Barbadensis Leaf Juice, PEG-7 Glyceryl Cocoate, Helianthus Annuus (Sunflower) Seed Extract, Tetrasodium EDTA, Sodium Styrene/PEG-10 Maleate/Nonoxynol-10 Maleate/ Acrylates Copolymer, Ammonium Nonoxynol-4 Sulfate, Citric Acid, Sodium Hydroxide, Mannitol, Cellulose, Tocopheryl Acetate, Hydroxypropyl Methylcellulose, Mica, Titanium Oxide (CI 77891), Yellow 10 (CI 47005), Red 40 (CI 16035), Iron Oxides ( CI 77492), Methylchloroisothiazolinone, Methylisothiazolinone.

When Using This Product (When using this product)

- Avoid contact with eyes. If contact occurs, rinse with water.

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

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Package Front and Back Labels (PACKAGE FRONT AND BACK LABELS)
  • 8.5 OZ Front Panel Label: eobf.jpg
  • 8.5 OZ Back Panel Label: eobb.jpg
Stop Using This Product and Ask Doctor If (Stop using this product and ask doctor if)
- Irritation or redness develops and lasts.


Advanced Ingredient Data


Raw Label Data

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