HAIR REGENERATOR- glycerin solution

HAIR REGENERATOR by

Drug Labeling and Warnings

HAIR REGENERATOR by is a Otc medication manufactured, distributed, or labeled by NUGGELA & SULE SL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS PURPOSE

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

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

• 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

• regenerates and stimulates the hair
• nourish the scalp and provides the needed strenght to the broken and damaged hair
• provides skin protection to the scalp

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

• regenerates and stimulates the hair
• nourish the scalp and provides the needed strenght to the broken and damaged hair
• provides skin protection to the scalp

Package Label

INGREDIENTS AND APPEARANCE

HAIR REGENERATOR 
glycerin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71578-002
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
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
CHLORPHENESIN (UNII: I670DAL4SZ)	0.03 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
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71578-002-01	10 mL in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product	07/27/2017

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(71578-002)