Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 5430f280-c005-46a8-b90d-bd4673d6d04f
Route
TOPICAL
Published
Effective Date 2011-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Triclosan (0.70 mL)
Inactive Ingredients
Water Disodium Laureth Sulfosuccinate Tea-dodecylbenzenesulfonate Sodium Laureth Sulfate Anhydrous Citric Acid Phenoxyethanol Sodium Chloride Edetate Sodium Aloe Vera Leaf Guar Gum Allantoin Fd&c Red No. 40 Fd&c Yellow No. 5 Sodium Benzoate Potassium Sorbate Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-07-01

Description

Active ingredient Triclosan, 0.70%


Medication Information

Warnings and Precautions

Warnings

For external use only

When using this product avoid contact with eyes.  In case of eye contact, flush with water

Indications and Usage

Uses

For hand and body washing to reduce bacteria on the skin

Dosage and Administration

Directions

Apply product onto washcloth or directly onto skin

Lather and wash for 15-20 seconds

Rinse and dry thoroughly

Description

Active ingredient Triclosan, 0.70%

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

Water, Disodium Laureth Sulfosuccinate, Sodium Laureth Sulfate, TEA-Dodecylbenzene Sulfonate, Citric Acid, Phenoxyethanol, Hyroxypropyl Guar Hydroxypropyltrimonium Chloride, Aloe Barbadensis Leaf Juice, Sodium Benzoate, Allantoin, Sodium Chloride, Tetrasodium EDTA, Potassium Sorbate, Fragrance, Yellow 5 (CI19140), Red 40 (CI 16035), Blue 1 (CI 42090).

Section 51945-4

DebMed Engineering Hand Hygiene Compliance

AntiMicrobial Body Wash and Shampoo

1L

33.8 fl oz

Made in USA

DMABHB1L

Section 55105-1

Purpose

Antimicrobial

Section 55106-9

Active ingredient

Triclosan, 0.70%


Structured Label Content

Indications and Usage (34067-9)

Uses

For hand and body washing to reduce bacteria on the skin

Dosage and Administration (34068-7)

Directions

Apply product onto washcloth or directly onto skin

Lather and wash for 15-20 seconds

Rinse and dry thoroughly

Warnings and Precautions (34071-1)

Warnings

For external use only

When using this product avoid contact with eyes.  In case of eye contact, flush with water

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

Water, Disodium Laureth Sulfosuccinate, Sodium Laureth Sulfate, TEA-Dodecylbenzene Sulfonate, Citric Acid, Phenoxyethanol, Hyroxypropyl Guar Hydroxypropyltrimonium Chloride, Aloe Barbadensis Leaf Juice, Sodium Benzoate, Allantoin, Sodium Chloride, Tetrasodium EDTA, Potassium Sorbate, Fragrance, Yellow 5 (CI19140), Red 40 (CI 16035), Blue 1 (CI 42090).

Section 51945-4 (51945-4)

DebMed Engineering Hand Hygiene Compliance

AntiMicrobial Body Wash and Shampoo

1L

33.8 fl oz

Made in USA

DMABHB1L

Section 55105-1 (55105-1)

Purpose

Antimicrobial

Section 55106-9 (55106-9)

Active ingredient

Triclosan, 0.70%


Advanced Ingredient Data


Raw Label Data

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