Caring Mill™ acne Spot Treatment

Caring Mill™ acne Spot Treatment
SPL v1
SPL
SPL Set ID f62000e3-e720-4283-8a00-a60f07747506
Route
TOPICAL
Published
Effective Date 2021-06-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sulfur (100 mg)
Inactive Ingredients
Water Camphor (synthetic) Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Isopropyl Alcohol Phenoxyethanol Propylene Carbonate Salicylic Acid Edetate Sodium Trolamine Zinc Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-06-21

Description

Sulfur 10%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Sulfur 10%

Use:

For the treatment of acne

Section 42229-5

HELPS CLEAR BLEMISHES FAST

Benefits

• Reduces redness and swelling

• Controls oil production

• Allows skin to heal

• Unblocks clogged pores

• Prevents new breakouts

• Will not cause redness or irritation

Results may vary

Maximum sulfur 10% penetrates pores to control acne

Camphor instantly cools and calms inflamed skin

Salicylic acid unblocks pores and sheds dead skin cells for faster healing

NOT TESTED ON ANIMALS

Made in the USA

Manufactured for FSA Store Inc.

240 W 37th St. 6th Floor

New York, NY 10018

Customer Help Line:

(844) 425-4948

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center right away.

Packaging

Warnings:

For external use only.

When using this product

• Do not use on broken skin or large areas of skin

• 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

• Stop use and ask a doctor if skin irritation occurs or gets worse

• Rinse right away with water if product gets in eyes

Drug Facts

Directions:

• Clean the skin thoroughly before using

• Apply a thin layer to entire affected area

• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor

• If bothersome dryness of peeling occurs, reduce application to once a day or every other day

Active Ingredient

Sulfur 10%

Other Ingredients:

Aqua (Deionized Water), Camphor, Carbomer, Isopropyl Alcohol, Phenoxyethanol, Propylene Carbonate, Salicylic Acid, Tetrasodium EDTA, Triethanolamine, Zinc Oxide.


Structured Label Content

Use:

For the treatment of acne

Section 42229-5 (42229-5)

HELPS CLEAR BLEMISHES FAST

Benefits

• Reduces redness and swelling

• Controls oil production

• Allows skin to heal

• Unblocks clogged pores

• Prevents new breakouts

• Will not cause redness or irritation

Results may vary

Maximum sulfur 10% penetrates pores to control acne

Camphor instantly cools and calms inflamed skin

Salicylic acid unblocks pores and sheds dead skin cells for faster healing

NOT TESTED ON ANIMALS

Made in the USA

Manufactured for FSA Store Inc.

240 W 37th St. 6th Floor

New York, NY 10018

Customer Help Line:

(844) 425-4948

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center right away.

Purpose

Acne Treatment

Packaging

Warnings:

For external use only.

When using this product

• Do not use on broken skin or large areas of skin

• 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

• Stop use and ask a doctor if skin irritation occurs or gets worse

• Rinse right away with water if product gets in eyes

Drug Facts

Directions:

• Clean the skin thoroughly before using

• Apply a thin layer to entire affected area

• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor

• If bothersome dryness of peeling occurs, reduce application to once a day or every other day

Active Ingredient

Sulfur 10%

Other Ingredients:

Aqua (Deionized Water), Camphor, Carbomer, Isopropyl Alcohol, Phenoxyethanol, Propylene Carbonate, Salicylic Acid, Tetrasodium EDTA, Triethanolamine, Zinc Oxide.


Advanced Ingredient Data


Raw Label Data

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