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

PATCHOLOGY BREAKOUT BOX 3-IN-1 ACNE TREATMENT by

Drug Labeling and Warnings

PATCHOLOGY BREAKOUT BOX 3-IN-1 ACNE TREATMENT by is a Otc medication manufactured, distributed, or labeled by Iontera, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 even 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

Company Information

DIST. BY RARE BEAUTY BRANDS, INC.

NORWOOD, MA 02062

DESIGNED IN THE USA

MADE IN KOREA

Product Packaging

PATCHOLOGY

pure pore perfection

BREAKOUT BOX
3-IN-1 ACNE TREATMENT KIT

24 BLEMISH SHRINKING SALICYLIC ACID DOTS
24 WHITEHEAD ABSORBING HYDROCOLLOID DOTS
3 DETOXIFYING CHARCOAL NOSE STRIPS

INGREDIENTS AND APPEARANCE

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

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

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

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

Part 1 of 3

WHITEHEAD ABSORBING HYDROCOLLOID DOTS 
other skin care preparations patch

Product Information
Route of Administration	TOPICAL

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

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

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

Part 2 of 3

BLEMISH SHRINKING SALICYLIC ACID DOTS 
salicylic acid patch

Product Information
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	06/03/2019

Part 3 of 3

DETOXIFYING CHARCOAL NOSE STRIPS 
other skin care preparations strip

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
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)

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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	06/03/2019

Labeler - Iontera, Inc (004818058)

Registrant - Iontera, Inc (004818058)