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NDC 37520-0007-06 M Skin Care Microneedle Blemish Patches 5 mg/g Details

M Skin Care Microneedle Blemish Patches 5 mg/g

M Skin Care Microneedle Blemish Patches is a TOPICAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by SALES AND PRODUCT SOLUTIONS. The primary component is SALICYLIC ACID.

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: 37520-0007-06
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Salicylic Acid Topical

Product Information

NDC	37520-0007
Product ID	37520-007_d22ff8d2-f2a1-ea70-e053-2a95a90ade88
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	M Skin Care Microneedle Blemish Patches
Proprietary Name Suffix	n/a
Non-Proprietary Name	Salicylic Acid 0.5%
Product Type	HUMAN OTC DRUG
Dosage Form	PATCH
Route	TOPICAL
Active Ingredient Strength	5
Active Ingredient Units	mg/g
Substance Name	SALICYLIC ACID
Labeler Name	SALES AND PRODUCT SOLUTIONS
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333D
Listing Certified Through	2022-12-31

Package

Package Images

NDC 37520-0007-06 (37520000706)

Pricing Information	N/A
NDC Package Code	37520-007-06
Billing NDC	37520000706
Package	1 g in 1 PACKET (37520-007-06)
Marketing Start Date	2021-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b9c21d5f-ef38-1ab8-e053-2a95a90a99b9 Details

Active Ingredient

Salicylic Acid 0.5%

Purpose

Acne Treatment

Use

For the Treatment of Acne

Clears up Acne blemish, 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.

Directions

Before applying patches, thoroughly cleanse and dry the affected area
Apply patch and press down for 15 seconds, patting the edges of patch to secure and contain the blemish.
Leave the patch in place for at least 6 hours or overnight to permit healing
To remove, gently peel back and discard
Cleanse affected area and repeat application with a fresh blemish patch, if desired.

Inactive Ingredients

Sodium Hyaluronate, Trehalose, Propanediol, Caprylyl Glycol, Madecassoside, Dipotassium Glycyrrhizate, Ethylhexylglycerin

M Skin Care Microneedle Blemish Patches

INGREDIENTS AND APPEARANCE

M SKIN CARE MICRONEEDLE BLEMISH PATCHES

salicylic acid 0.5% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37520-007
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
TREHALOSE (UNII: B8WCK70T7I)
PROPANEDIOL (UNII: 5965N8W85T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MADECASSOSIDE (UNII: CQ2F5O6YIY)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37520-007-06	1 g in 1 PACKET; Type 0: Not a Combination Product	01/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	01/01/2021

Labeler - SALES AND PRODUCT SOLUTIONS (037519852)

Registrant - SALES AND PRODUCT SOLUTIONS (037519852)

Name	Address	ID/FEI	Business Operations
Establishment
Small Lab Co., Ltd.		688438425	manufacture(37520-007)

Revised: 12/2021

Document Id: d22ff8d2-f2a1-ea70-e053-2a95a90ade88

Set id: b9c21d5f-ef38-1ab8-e053-2a95a90a99b9

Version: 2

Effective Time: 20211202