OTC Medication Information: M Skin Care Blemish Patches

M SKIN CARE BLEMISH PATCHES- salicylic acid patch
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Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ACTIVE INGREDIENT

Salicylic Acid 0.5%

PURPOSE

Acne Treatment

INDICATIONS & USAGE

For the treatment of acne

Clears up acne blemishes, blackheads and allows skin to heal.

WARNINGS

For External Use Only.

When using this product

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.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

Before application, thoroughly clean and dry affected area.
Apply an appropriately sized patch to blemish
Pat edges of patch to secure and contain blemish.
Leave in place for at least 8 hours or overnight to permit healing
To remove, gently peel back patch and discard.
Cleanse affected area and repeat application with a fresh blemish patch, if desired.
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

INACTIVE INGREDIENT

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

M Skin Care Blemish Patches

M SKIN CARE BLEMISH PATCHES salicylic acid 0.5% patch

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37520-102 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 5 g

Inactive Ingredients Ingredient Name Strength BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) STREPTOCOCCUS PYOGENES ALCOHOL MELALEUCA ALTERNIFOLIA LEAF 2-PROPENOIC ACID, 2-(PHOSPHONOOXY)- PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER PHENOXYETHANOL WATER POLYSORBATE 80 POVIDONE, UNSPECIFIED BUTYLENE GLYCOL EPILOBIUM ANGUSTIFOLIUM LEAF VITIS VINIFERA SEED SODIUM METABISULFITE PHYTOSPHINGOSINE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:37520-102-09 1 PATCH in 1 POUCH None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 07/01/2020

Labeler — Sales and Product Solutions (037519852)

Revised: 07/2020 Sales and Product Solutions