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

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%


Medication Information

Purpose

Antibacterial

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.

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%

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

Purpose

Antibacterial

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.

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

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%

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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