Drug Facts

Active ingredient(s)

Salicylic Acid 0.5%

Purpose

Acne Treatment

Use

For the treatment of acne

Warnings

For external use only

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.

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

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

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.

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

Product Packaging

breakout box rev

PATCHOLOGY BREAKOUT BOX 3-IN-1 ACNE TREATMENT
salicylic acid kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72204-002

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72204-002-01	1 in 1 BOX; Type 0: Not a Combination Product	06/03/2019

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 PATCH	0.5 g
Part 2	0 PACKET	1
Part 3	0 PACKET	1

Part 1 of 3

BLEMISH SHRINKING SALICYLIC ACID DOTS
salicylic acid patch

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE (UNII: FZ989GH94E)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
ALCOHOL (UNII: 3K9958V90M)
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
TEA TREE OIL (UNII: VIF565UC2G)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		24 in 1 PACKET
1		0.5 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M006	06/03/2019

Part 2 of 3

DETOXIFYING CHARCOAL NOSE STRIPS
other skin care preparations strip

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
INGR	COPOVIDONE K25-31 (UNII: D9C330MD8B)
INGR	BENTONITE (UNII: A3N5ZCN45C)
INGR	ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
INGR	POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
INGR	TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
INGR	KAOLIN (UNII: 24H4NWX5CO)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	1,2-HEXANEDIOL (UNII: TR046Y3K1G)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	MENTHOL (UNII: L7T10EIP3A)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
INGR	GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		3 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		06/03/2019

Part 3 of 3

ABSORBING HYDROCOLLOID DOTS
other skin care preparations patch

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
INGR	POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
INGR	POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		24 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		06/03/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M006	06/03/2019

Labeler - Iontera, Inc (004818058)

Registrant - Iontera, Inc (004818058)

PATCHOLOGY BREAKOUT BOX 3-IN-1 ACNE TREATMENT KIT