SPL v4
SPL
SPL Set ID 1496876c-2fc8-449d-bd6c-0419dd77fb7c
Route
TOPICAL
Published
Effective Date 2013-09-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Triclosan (3.3 mg)
Inactive Ingredients
Water Sodium C14-16 Olefin Sulfonate Sodium Laureth Sulfate Coco Diethanolamide Sodium Chloride Peg-150 Distearate Citric Acid Monohydrate Glycerin Edetate Disodium Aloe Vera Leaf Methylchloroisothiazolinone Methylisothiazolinone D&c Red No. 33 Fd&c Red No. 40

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-08-30
Description

Active Ingredient                                    Purpose Triclosan 0.15%...................................Antibacterial

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.

Stop use and ask a doctor if irritation and redness develops.

Indications and Usage

Uses  for hand washing to decrease bacteria on the skin

Dosage and Administration

Directions

  • pump into hands
  • lather vigorously for at least 15 seconds
  • rinse and dry thoroughly.
Description

Active Ingredient                                    Purpose Triclosan 0.15%...................................Antibacterial

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, sodium c14-16 olefin sulfonate, sodium laureth sulfate, cocamide DEA, sodium chloride, PEG-150 distearate, fragrance, citric acid, glycerin, disodium EDTA, aloe barbadensis leaf juice, methylchloroisothiazolinone, methylisothiazolinone, d&c red no. 33, fd&c red no. 40.

Section 51945-4

Section 55105-1

Antibacterial Moisturizing Hand Soap

Strawberry Pomegranate Scent

  • Kills the germs
  • Eliminates bacteria on hands
  • Moisturizes the skin

Section 55106-9

Active Ingredient                                    Purpose

Triclosan 0.15%...................................Antibacterial

Section 60561-8

Other Information

  • store at room temperature

DISTRIBUTED BY:

REJOICE INTERNATIONAL, INC. 

48325 BINGHAMPTON DR., NORTHVILLE, MI 48168, USA

MADE IN CHINA

Structured Label Content

Indications and Usage (34067-9)

Uses  for hand washing to decrease bacteria on the skin

Dosage and Administration (34068-7)

Directions

  • pump into hands
  • lather vigorously for at least 15 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.

Stop use and ask a doctor if irritation and redness develops.

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, sodium c14-16 olefin sulfonate, sodium laureth sulfate, cocamide DEA, sodium chloride, PEG-150 distearate, fragrance, citric acid, glycerin, disodium EDTA, aloe barbadensis leaf juice, methylchloroisothiazolinone, methylisothiazolinone, d&c red no. 33, fd&c red no. 40.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antibacterial Moisturizing Hand Soap

Strawberry Pomegranate Scent

  • Kills the germs
  • Eliminates bacteria on hands
  • Moisturizes the skin

Section 55106-9 (55106-9)

Active Ingredient                                    Purpose

Triclosan 0.15%...................................Antibacterial

Section 60561-8 (60561-8)

Other Information

  • store at room temperature

DISTRIBUTED BY:

REJOICE INTERNATIONAL, INC. 

48325 BINGHAMPTON DR., NORTHVILLE, MI 48168, USA

MADE IN CHINA

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:22.870409 · Updated: 2026-03-14T23:00:47.249871