Label: DERMA FIRST MASK- glycerin kit
-
Contains inactivated NDC Code(s)
NDC Code(s): 72312-0014-1, 72312-0015-1, 72312-0016-1, 72312-0017-1 - Packager: CELLALAB
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 24, 2018
If you are a healthcare professional or from the pharmaceutical industry 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
- INDICATIONS & USAGE
-
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
-
INGREDIENTS AND APPEARANCE
DERMA FIRST MASK
glycerin kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72312-0014 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72312-0014-1 1 in 1 KIT; Type 0: Not a Combination Product 06/01/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 POUCH 1 mL Part 2 1 POUCH 25 mL Part 3 1 POUCH 1 mL Part 1 of 3 DERMA FIRST AMPOULE
glycerin gelProduct Information Item Code (Source) NDC:72312-0015 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 2 g in 100 mL 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:72312-0015-1 1 mL in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/01/2018 Part 2 of 3 DERMA FIRST MASK
niacinamide liquidProduct Information Item Code (Source) NDC:72312-0016 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 2 g in 100 mL 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:72312-0016-1 25 mL in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/01/2018 Part 3 of 3 DERMA FIRST
glycerin creamProduct Information Item Code (Source) NDC:72312-0017 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 7 g in 100 mL 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:72312-0017-1 1 mL in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/01/2018 Labeler - CELLALAB (690452262) Registrant - CELLALAB (690452262) Establishment Name Address ID/FEI Business Operations SAMSUNG MEDICOS. CO., LTD. Hyangnam Factory 689851701 manufacture(72312-0014) Establishment Name Address ID/FEI Business Operations CELLALAB 690452262 label(72312-0014)
