Softie Soap® 

Softie Soap® 
SPL v1
SPL
SPL Set ID fa5c12db-c2b5-4420-ac41-de771d356c2a
Route
TOPICAL
Published
Effective Date 2021-02-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Water Sodium Laureth-3 Sulfate Cocamidopropyl Betaine Coco Glucoside Glyceryl Oleate Coco Diethanolamide Glycerin Phenoxyethanol Sodium Benzoate Potassium Sorbate Citral .beta.-citronellol, (r)- Limonene, (+)- Linalool, (+/-)- Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-02-01

Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Use

• For handwashing to decrease bacteria on the skin

Section 42229-5

New!

Softsoap® is a registered trademark of Colgate-Palmolive Co. which has not manufactured, distributed or sponsored this product.

FDA APPROVED

Designed & Developed

By: Primax USA LLC

Brooklyn, NY 11204

MADE IN TURKEY

Packaging

Drug Facts

Directions:

Pump into hands, lather vigorously for at least 15 seconds, rinse and dry thoroughly.

Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredients

Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Coco-Glucoside (and) Glyceryl Oleate, Cocamide DEA (and) Glycerin, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate, Parfum, Citral, Citronellol, Limonene, Linalool, CI 19140.

Keep Out of Reach of Children.

If swallowed get medical help or contact a Poison Control Center right away.

Warnings: for External Use Only.

Avoid contact with eyes, if eye contact occurs, flush with water.

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


Structured Label Content

Use

• For handwashing to decrease bacteria on the skin

Section 42229-5 (42229-5)

New!

Softsoap® is a registered trademark of Colgate-Palmolive Co. which has not manufactured, distributed or sponsored this product.

FDA APPROVED

Designed & Developed

By: Primax USA LLC

Brooklyn, NY 11204

MADE IN TURKEY

Purpose

Antibacterial

Packaging

Drug Facts

Directions: (DIRECTIONS:)

Pump into hands, lather vigorously for at least 15 seconds, rinse and dry thoroughly.

Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Coco-Glucoside (and) Glyceryl Oleate, Cocamide DEA (and) Glycerin, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate, Parfum, Citral, Citronellol, Limonene, Linalool, CI 19140.

Keep Out of Reach of Children. (KEEP OUT OF REACH OF CHILDREN.)

If swallowed get medical help or contact a Poison Control Center right away.

Warnings: for External Use Only. (WARNINGS: FOR EXTERNAL USE ONLY.)

Avoid contact with eyes, if eye contact occurs, flush with water.

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


Advanced Ingredient Data


Raw Label Data

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