Patchology Breakout Box 3-in-1 Acne Treatment Kit

Patchology Breakout Box 3-in-1 Acne Treatment Kit
SPL v4
SPL
SPL Set ID 8a6c911b-5714-0884-e053-2a95a90a5d3c
Route
TOPICAL
Published
Effective Date 2019-06-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (5 mg)
Inactive Ingredients
Phytosphingosine Phenoxyethanol Polysorbate 80 Povidone Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Alcohol Epilobium Angustifolium Flowering Top Hyaluronate Sodium Vitis Vinifera Seed Butylene Glycol Water Tea Tree Oil Bisulfite Ion

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-06-03

Description

Salicylic Acid 0.5%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Salicylic Acid 0.5%

Use

For the treatment of acne

Section 50565-1

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

Section 50567-7

When using this product skin irritation and dryness is likely to occur if you use another topical acne product at the same time. If irritation occurs, only one medication should be used.

Section 50570-1

Do not use if you are allergic to the dressing or to any of the components.

Warnings

For external use only

Directions
  • Cleanse thoroughly before applying medication.
  • Apply the sticker on the affected areas. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor. If bothersome dyrness or peeling occurs, reduce application to once a day or every other day.
  • Sensitivity test for a new user: Apply product to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.
Product Packaging

Company Information

DIST. BY RARE BEAUTY BRANDS, INC.

NORWOOD, MA 02062

DESIGNED IN THE USA

MADE IN KOREA

Active Ingredient(s)

Salicylic Acid 0.5%

Inactive Ingredients

Acrylates Copolymer, Vinyl Caprolactam/VP/Dimethylaminoethyl Methacrylate Copolymer, Water (Aqua/Eau), Alcohol Denat., Melaleuca Alternifolia (Tea Tree) Leaf Oil, Epilobium Angustifolium Flower/Leaf/Stem Extract, Volcanic Ash, Sodium Hyaluronate, Vitis Vinifera (Grape) Seed Extract, Sodium Metabisulfite, Butylene Glycol, Phytosphingosine, Phenoxyethanol, Polysorbate 80, PVP.

Questions Or Comments?

Call toll free 1-888-243-0646 24/7, 365

Report serious adverse reactions to: 83 Morse St. Suite 8A Norwood, MA 02062


Structured Label Content

Use

For the treatment of acne

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 50567-7 (50567-7)

When using this product skin irritation and dryness is likely to occur if you use another topical acne product at the same time. If irritation occurs, only one medication should be used.

Section 50570-1 (50570-1)

Do not use if you are allergic to the dressing or to any of the components.

Purpose

Acne Treatment

Warnings

For external use only

Directions
  • Cleanse thoroughly before applying medication.
  • Apply the sticker on the affected areas. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor. If bothersome dyrness or peeling occurs, reduce application to once a day or every other day.
  • Sensitivity test for a new user: Apply product to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.
Product Packaging

Company Information

DIST. BY RARE BEAUTY BRANDS, INC.

NORWOOD, MA 02062

DESIGNED IN THE USA

MADE IN KOREA

Active Ingredient(s) (Active ingredient(s))

Salicylic Acid 0.5%

Inactive Ingredients (Inactive ingredients)

Acrylates Copolymer, Vinyl Caprolactam/VP/Dimethylaminoethyl Methacrylate Copolymer, Water (Aqua/Eau), Alcohol Denat., Melaleuca Alternifolia (Tea Tree) Leaf Oil, Epilobium Angustifolium Flower/Leaf/Stem Extract, Volcanic Ash, Sodium Hyaluronate, Vitis Vinifera (Grape) Seed Extract, Sodium Metabisulfite, Butylene Glycol, Phytosphingosine, Phenoxyethanol, Polysorbate 80, PVP.

Questions Or Comments? (Questions or comments?)

Call toll free 1-888-243-0646 24/7, 365

Report serious adverse reactions to: 83 Morse St. Suite 8A Norwood, MA 02062


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)