Breakout Control Acne Treatment

Breakout Control Acne Treatment
SPL v1
SPL
SPL Set ID 58d4eadb-18d2-489e-81f9-5b35bc500367
Route
TOPICAL
Published
Effective Date 2012-03-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (5 mL)
Inactive Ingredients
Water Pentylene Glycol Squalene Polysorbate 60 Aloe Vera Leaf Fytic Acid Phenoxyethanol Potassium Sorbate Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-03-26

Description

Active ingredient                 Purpose Benzoyl Peroxide 5%          Acne treatment


Medication Information

Warnings and Precautions

Warnings

For external use only

When using this product

- Skin irritation and dryness is more likely to occur if you use antoher topical acne medication at the same time. If irritation occurs only use only one topical acne medication at a time.

- Avoid unnecessary sun exposure and use a sunscreen

- Avoid contact with with the eyes lips and mouth

- Avoid contact with hair and dyed fabrics, which may be bleached by this product

- Skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling . Irritation may be reduced by using the product less frequently or in a lower concentration.

- Do not use if you:

Have very sensitive skin

Are sensitive to benzoyl peroxide

Indications and Usage

Stop use and ask a doctor if:

irritation becomes severe

Dosage and Administration

Directions

Cleanse the skin thoroughly before applying this product

cover the entire with a thin layer one to three times daily

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 or peeling occurs, reduce application to once a day or every other day

If going outside apply sunscreen after using this product. If irritation or sensitivity develops stop use of both products and ask a  doctor.

Description

Active ingredient                 Purpose Benzoyl Peroxide 5%          Acne treatment

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 (Aqua,Eau), Pentylene Glycol, Hydroxyethyl Acrylates/Sodium Acryloyldimethyl Taurate Copolymer, Squalene, Polysorbate 60, Aloe Bardadensis (Aloe) Leaf Juice powder, Phytic Acid, Phyenoxyethanol, Potassium Sorbate, Disodium EDTA.









Section 51945-4

Bioelements

Breakout control

Emergency Blemish Lotion with Benzoyl Peroxide

29 mL/ 1 Fl. Oz.















Section 55105-1

Uses

For the treatment of acne

Helps prevent new acne blemishes

Section 55106-9

Active ingredient                 Purpose

Benzoyl Peroxide 5%          Acne treatment


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if:

irritation becomes severe

Dosage and Administration (34068-7)

Directions

Cleanse the skin thoroughly before applying this product

cover the entire with a thin layer one to three times daily

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 or peeling occurs, reduce application to once a day or every other day

If going outside apply sunscreen after using this product. If irritation or sensitivity develops stop use of both products and ask a  doctor.

Warnings and Precautions (34071-1)

Warnings

For external use only

When using this product

- Skin irritation and dryness is more likely to occur if you use antoher topical acne medication at the same time. If irritation occurs only use only one topical acne medication at a time.

- Avoid unnecessary sun exposure and use a sunscreen

- Avoid contact with with the eyes lips and mouth

- Avoid contact with hair and dyed fabrics, which may be bleached by this product

- Skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling . Irritation may be reduced by using the product less frequently or in a lower concentration.

- Do not use if you:

Have very sensitive skin

Are sensitive to benzoyl peroxide

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 (Aqua,Eau), Pentylene Glycol, Hydroxyethyl Acrylates/Sodium Acryloyldimethyl Taurate Copolymer, Squalene, Polysorbate 60, Aloe Bardadensis (Aloe) Leaf Juice powder, Phytic Acid, Phyenoxyethanol, Potassium Sorbate, Disodium EDTA.









Section 51945-4 (51945-4)

Bioelements

Breakout control

Emergency Blemish Lotion with Benzoyl Peroxide

29 mL/ 1 Fl. Oz.















Section 55105-1 (55105-1)

Uses

For the treatment of acne

Helps prevent new acne blemishes

Section 55106-9 (55106-9)

Active ingredient                 Purpose

Benzoyl Peroxide 5%          Acne treatment


Advanced Ingredient Data


Raw Label Data

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