sulfo-lo cleansing bar soap

sulfo-lo cleansing bar soap
SPL v6
SPL
SPL Set ID 89577417-76a0-cb04-e053-2995a90a5733
Route
topical
Published
Effective Date 2023-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
sulfur (30 mg)
Inactive Ingredients
.alpha.-tocopherol acetate, d- sodium tallowate, beef sodium cocoate sodium palm kernelate water glycerin sodium chloride pentasodium pentetate etidronate tetrasodium brown iron oxide titanium dioxide shea butter basic yellow 5

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 1965-11-01

Purpose

Acne Treatment

Description

Sulfur 3%


Medication Information

Warnings

For external use only • Avoid contact with eyes, wash with water if exposed

Uses

Deep cleansing antibacterial soap for management of acne, blackheads and comedones.

Purpose

Acne Treatment

Directions

• Work into a lather and rinse with warm water • Use daily as skin cleanser or as directed by a physician.

Other Information

Store at 20˚-25˚C (68˚-77˚F) [see USP Controlled Room Temperature].

Inactive Ingredients

Sodium Tallowate, Sodium Cocoate/Sodium Palm Kernelate, Water (Aqua), Glycerin, Fragrance (Parfum), Sodium Chloride, Butyrospermum parkii (Shea) Butter, Yellow 5 (CI19140), Titanium Dioxide (CI77891), Pentasodium Pentetate, Tetrasodium Etidronate, Iron Oxides (CI77492), Tocopheryl Acetate

Description

Sulfur 3%

Section 51945-4

NDC 0316-0118-35

sulfo lo®

Cleansing Bar Soap

Helps Treat and Manage Acne, Blackheads and Comedones

DERMATOLOGIST RECOMMENDED

Net wt. 3.5oz (99 grams)

Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604

www.crownlaboratories.com | 800.334.4286 | Made in the USA

P9100.06

•do No Use On

• broken skin • large areas of skin

Active Ingredients

Sulfur 3%

• When Using This Product

• apply only to areas with acne • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. • If irritation occurs, only use one topical acne medication at a time • If undue irritation persists consult a physician

• Keep Out of Reach of Children.

• If swallowed, get medical help or contact a Poison Control Center.


Structured Label Content

Warnings

For external use only • Avoid contact with eyes, wash with water if exposed

Uses

Deep cleansing antibacterial soap for management of acne, blackheads and comedones.

Purpose

Acne Treatment

Directions

• Work into a lather and rinse with warm water • Use daily as skin cleanser or as directed by a physician.

Other Information (Other information)

Store at 20˚-25˚C (68˚-77˚F) [see USP Controlled Room Temperature].

Inactive Ingredients (Inactive ingredients)

Sodium Tallowate, Sodium Cocoate/Sodium Palm Kernelate, Water (Aqua), Glycerin, Fragrance (Parfum), Sodium Chloride, Butyrospermum parkii (Shea) Butter, Yellow 5 (CI19140), Titanium Dioxide (CI77891), Pentasodium Pentetate, Tetrasodium Etidronate, Iron Oxides (CI77492), Tocopheryl Acetate

Section 51945-4 (51945-4)

NDC 0316-0118-35

sulfo lo®

Cleansing Bar Soap

Helps Treat and Manage Acne, Blackheads and Comedones

DERMATOLOGIST RECOMMENDED

Net wt. 3.5oz (99 grams)

Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604

www.crownlaboratories.com | 800.334.4286 | Made in the USA

P9100.06

•do No Use On (•Do no use on)

• broken skin • large areas of skin

Active Ingredients (Active ingredients)

Sulfur 3%

• When Using This Product (• When using this product)

• apply only to areas with acne • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. • If irritation occurs, only use one topical acne medication at a time • If undue irritation persists consult a physician

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

• If swallowed, get medical help or contact a Poison Control Center.


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