NDC | 71380-0004-1 |
Set ID | 4f9a9d09-10f4-1c74-e054-00144ff88e88 |
Category | HUMAN OTC DRUG LABEL |
Packager | Nature4 co., Ltd. |
Generic Name | |
Product Class | Adenosine Receptor Agonist |
Product Number | |
Application Number |
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
WARNINGS
1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).
1) Occurrence of red spots, swelling, itchiness, and other skin irritation
2) If the symptoms above occur after the application area is exposed to direct sunlight
2. Do not use on open wounds, eczema, and other skin irritations
3. Precaution for Storage and Handling
1) Close the lid after use
2) Keep out of reach of infants and children
3) Do not to store in a place with high/low temperature and exposed to direct sunlight4. Use as avoiding eye areas.
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BRUCKE A.C.C. CURE AMPOULE
adenosine, niacinamide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71380-0004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE 0.04 g in 100 mL NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength BUTYLENE GLYCOL (UNII: 3XUS85K0RA) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71380-0004-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 05/15/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/15/2017 Labeler - Nature4 co., Ltd. (694208420) Registrant - Nature4 co., Ltd. (694208420) Establishment Name Address ID/FEI Business Operations Nature4 co., Ltd. 694208420 manufacture(71380-0004) , label(71380-0004) , pack(71380-0004)