Label: PIMPLEPATCH BY GLAM UP- salicylic acid kit
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Contains inactivated NDC Code(s)
NDC Code(s): 73085-0001-1, 73085-0002-1, 73085-0003-1, 73085-0003-2 - Packager: Spigen Korea Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated August 25, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
step 1. microneedle patch
1. after cleansing apply onto dry skin, press lightly for 10 seconds and leave on for 2~3 hours
2. do not repeatedly apply on same area (make sure the needle area of the patch avoids water)
step 2. hydrocolloid
1. after cleansing apply on to dry skin, pick the suitable hydrocolloid patch size and apply on trouble spot
2. for faster healing of trouble spot(s), avoid repeatly changing patches. use the small patch size for areas that are difficult to reach (i.e., side of nose)
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WARNINGS
1. Do not use in the following cases(Eczema and scalp wounds)
2.Side Effects
1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor
3.General Precautions
1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
2)This product is for exeternal use only. Do not use for internal use
4.Storage and handling precautions
1)If possible, avoid direct sunlight and store in cool and area of low humidity
2)In order to maintain the quality of the product and avoid misuse
3)Avoid placing the product near fire and store out in reach of children - DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PIMPLEPATCH BY GLAM UP
salicylic acid kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73085-0001 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73085-0001-1 1 in 1 CARTON; Type 0: Not a Combination Product 05/31/2019 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 2 PATCH 2 mg Part 2 1 PATCH 1 mg in 2 Part 1 of 2 HYDROCOLLOID
melaleuca alternifolia leaf oil patchProduct Information Item Code (Source) NDC:73085-0003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) (MELALEUCA ALTERNIFOLIA LEAF - UNII:G43C57162K) MELALEUCA ALTERNIFOLIA LEAF 1 mg in 100 mg Inactive Ingredients Ingredient Name Strength SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73085-0003-1 1 mg in 1 PATCH; Type 0: Not a Combination Product 2 NDC:73085-0003-2 2 mg in 1 PATCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/28/2019 Part 2 of 2 MICRONEEDLE
salicylic acid patchProduct Information Item Code (Source) NDC:73085-0002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.44 mg in 100 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73085-0002-1 2 mg in 1 PATCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/10/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/10/2019 Labeler - Spigen Korea Co., Ltd. (688278594) Registrant - Spigen Korea Co., Ltd. (688278594) Establishment Name Address ID/FEI Business Operations Spigen Korea Co., Ltd. 688278594 pack(73085-0001) , manufacture(73085-0001)
