HAIR REGENERATOR- glycerin solution 
NUGGELA & SULE SL

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.

----------

Hair Regenerator topical solution

ACTIVE INGREDIENTS PURPOSE

Glycerin 4%.................... Skin Protectant

BOX

Warnings

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

Whhen using this product do not get into eyes.

Children under 6 months: as a doctor.

WARNINGS

Stop use and ask a doctor if rash occurs

Children under 6 months: ask a doctor

Warnings

Keep out of reach of children

Questions or comments?

+ 305 670 0979 M-F 9:00 am to 5:00 pm

Other Information

. keep the product in a cool and dry place

Directions

  • apply one dose every 2 days for a minimun of 30 days
  • for better results, combine this product with Nuggela & Sule Premium shampoo and Conditioner

Uses

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

Box

HAIR REGENERATOR 
glycerin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71578-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71578-001-021 in 1 BOX07/27/2017
1NDC:71578-001-0110 mL in 1 AMPULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/27/2017
Labeler - NUGGELA & SULE SL (466134663)
Registrant - NUGGELA & SULE SL (466134663)
Establishment
NameAddressID/FEIBusiness Operations
NUGGELA & SULE SL466134663manufacture(71578-001)

Revised: 5/2020
Document Id: a6b4725b-376e-059e-e053-2995a90a38e0
Set id: 5556d99a-3235-4c7a-e054-00144ff88e88
Version: 2
Effective Time: 20200528
 
NUGGELA & SULE SL