Label: HAIR REGENERATOR- glycerin solution
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Contains inactivated NDC Code(s)
NDC Code(s): 71578-001-01, 71578-001-02 - Packager: NUGGELA & SULE SL
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 May 28, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS PURPOSE
- Warnings
- Questions or comments?
- Other Information
- Directions
- Uses
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Inactive Ingredients
AQUA, ALCOHOL DENAT, PROPYLENE GLYCOL, PLACENTAL PROTEIN, METHYLPROPANEDIOL, HYDROLYZED SOY PROTEIN, PROPANEDIOL, CAPRYLYL GLYCOL, GLYCOGEN, POLYQUATERNIUM-11, PEG-40 HYDROGENATED CASTOR OIL
DISODIUM EDTA, PHENOXYETHANOL, PARFUM, PANTHENOL, ZINC PCA, GLUCOSE, PHENYLPROPANOL, ORNITHINE HCL, NIACINAMIDE, ARGININE HCL, CHLORPHENESIN, LEPIDIUM MEYENII ROOT EXTRACT, PYRIDOXINE HCL, GLUCOSAMINE HCL, CITRULLINE, SODIUM SUCCINATE, SODIUM HYDROXIDE,SORBIC ACID, BIOTIN, D&C Yellow No. 5, FD&C Blue No.1, LIMONENE, LINALOOL
- Uses
- Package Label
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INGREDIENTS AND APPEARANCE
HAIR REGENERATOR
glycerin solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71578-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 4 mg in 1 mL Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.0001 mg in 1 mL FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.0001 mg in 1 mL BIOTIN (UNII: 6SO6U10H04) 0.002 mg in 1 mL LINALOOL, (-)- (UNII: 3U21E3V8I2) 0.0001 mg in 1 mL WATER (UNII: 059QF0KO0R) 64.33 mg in 1 mL DIPROPYLENE GLYCOL (UNII: E107L85C40) 6.82 mg in 1 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.17 mg in 1 mL HYDROLYZED PLACENTAL PROTEIN (BOVINE) (UNII: KR5CS6RBH9) 6.53 mg in 1 mL METHYLPROPANEDIOL (UNII: N8F53B3R4R) 2.4 mg in 1 mL SOY PROTEIN (UNII: R44IWB3RN5) 1.97 mg in 1 mL PROPANEDIOL (UNII: 5965N8W85T) 0.98 mg in 1 mL LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.01 mg in 1 mL CAPRYLYL GLYCOL (UNII: 00YIU5438U) 0.52 mg in 1 mL GLYCOGEN (UNII: 309GSC92U1) 0.5 mg in 1 mL POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS) 0.4 mg in 1 mL PEG-40 CASTOR OIL (UNII: 4ERD2076EF) 0.25 mg in 1 mL EDETATE DISODIUM (UNII: 7FLD91C86K) 0.2 mg in 1 mL ZINC PIDOLATE (UNII: C32PQ86DH4) 0.1 mg in 1 mL DEXTROSE (UNII: IY9XDZ35W2) 0.1 mg in 1 mL PHENYLPROPANOL (UNII: 0F897O3O4M) 0.07 mg in 1 mL ORNITHINE HYDROCHLORIDE (UNII: HBK84K66XH) 0.07 mg in 1 mL NIACINAMIDE (UNII: 25X51I8RD4) 0.07 mg in 1 mL ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y) 0.07 mg in 1 mL CHLORPHENESIN (UNII: I670DAL4SZ) 0.03 mg in 1 mL PANTHENOL (UNII: WV9CM0O67Z) 0.106 mg in 1 mL LEPIDIUM MEYENII ROOT (UNII: HP7119212T) 0.03 mg in 1 mL PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) 0.02 mg in 1 mL GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY) 0.02 mg in 1 mL CITRULLINE (UNII: 29VT07BGDA) 0.02 mg in 1 mL SODIUM SUCCINATE HEXAHYDRATE (UNII: U16QOD6C4E) 0.01 mg in 1 mL SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.0044 mg in 1 mL SORBIC ACID (UNII: X045WJ989B) 0.002 mg in 1 mL ALCOHOL (UNII: 3K9958V90M) 10 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71578-001-02 1 in 1 BOX 07/27/2017 1 NDC:71578-001-01 10 mL in 1 AMPULE; 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 07/27/2017 Labeler - NUGGELA & SULE SL (466134663) Registrant - NUGGELA & SULE SL (466134663) Establishment Name Address ID/FEI Business Operations NUGGELA & SULE SL 466134663 manufacture(71578-001)
