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NDC 72204-0001-11 PATCHOLOGY THE BLEMISH BUSTER BREAKOUT BOX 3-IN-1 ACNE TREATMENT Details

PATCHOLOGY THE BLEMISH BUSTER BREAKOUT BOX 3-IN-1 ACNE TREATMENT

PATCHOLOGY THE BLEMISH BUSTER BREAKOUT BOX 3-IN-1 ACNE TREATMENT is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by Rare Beauty Brands, Inc.. The primary component is .

MedlinePlus Drug Summary

Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions that involve scaling or overgrowth of skin cells such as psoriasis (a skin disease in which red, scaly patches form on some areas of the body), ichthyoses (inborn conditions that cause skin dryness and scaling), dandruff, corns, calluses, and warts on the hands or feet. Topical salicylic acid should not be used to treat genital warts, warts on the face, warts with hair growing from them, warts in the nose or mouth, moles, or birthmarks. Salicylic acid is in a class of medications called keratolytic agents. Topical salicylic acid treats acne by reducing swelling and redness and unplugging blocked skin pores to allow pimples to shrink. It treats other skin conditions by softening and loosening dry, scaly, or thickened skin so that it falls off or can be removed easily.

Related Packages: 72204-0001-11
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Salicylic Acid Topical

Product Information

NDC	72204-0001
Product ID	72204-001_ebe40ce4-95ec-e213-e053-2a95a90ae941
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	PATCHOLOGY THE BLEMISH BUSTER BREAKOUT BOX 3-IN-1 ACNE TREATMENT
Proprietary Name Suffix	n/a
Non-Proprietary Name	SALICYLIC ACID
Product Type	HUMAN OTC DRUG
Dosage Form	KIT
Route	n/a
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
Labeler Name	Rare Beauty Brands, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333D
Listing Certified Through	2023-12-31

Package

Package Images

NDC 72204-0001-11 (72204000111)

Pricing Information	N/A
NDC Package Code	72204-001-11
Billing NDC	72204000111
Package	1 KIT in 1 BOX (72204-001-11) * 24 PATCH in 1 PACKET / .5 g in 1 PATCH * 3 STRIP in 1 PACKAGE
Marketing Start Date	2018-09-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6f1cd75c-5fe3-8aeb-e053-2a91aa0a7206 Details

Active ingredient(s)

Salicylic Acid 0.5%

Purpose

Acne Treatment

Use

For the treatment of acne

Warnings

For external use only. 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 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. 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.

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

Report serious adverse reactions to: 220 Norwood Park South

Suite 2203

Norwood, MA 02062

SPL UNCLASSIFIED SECTION

DIST. BY/PAR IONTERA, INC.,

NORWOOD, MA 02062

DESIGNED IN THE USA

MADE IN KOREA

PATCHOLOGY.COM

PRINCIPAL DISPLAY PANEL

the blemish buster

BREAKOUT BOX

3-IN-1 ACNE TREATMENT KIT

24 PIMPLE-SHRINKING SALICYLIC ACID DOTS

24 WHITEHEAD-ABSORBING HYDROCOLLOID DOTS

3 BLACKHEAD-ELIMINATING NOSE STRIPS

INGREDIENTS AND APPEARANCE

PATCHOLOGY THE BLEMISH BUSTER BREAKOUT BOX 3-IN-1 ACNE TREATMENT

salicylic acid kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72204-001

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72204-001-11	1 in 1 BOX; Type 0: Not a Combination Product	09/01/2018

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

Part 1 of 2
PIMPLE-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 WHOLE (UNII: C278QS9YBT)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
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 final	part333D	09/01/2018

Part 2 of 2
BLACKHEAD-ELIMINATING NOSE STRIPS other skin care preparations strip

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	HAMAMELIS VIRGINIANA WHOLE (UNII: V663Q8TEFU)
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 PACKAGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		09/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	09/01/2018

Labeler - Rare Beauty Brands, Inc. (004818058)

Registrant - Rare Beauty Brands, Inc. (004818058)

Revised: 10/2022

Document Id: ebe40ce4-95ec-e213-e053-2a95a90ae941

Set id: 6f1cd75c-5fe3-8aeb-e053-2a91aa0a7206

Version: 4

Effective Time: 20221025