Effective Hair Strengthen (Glycerin) Solution [Nuggela & Sule Sl] -

EFFECTIVE HAIR STRENGTHEN (GLYCERIN) SOLUTION [NUGGELA & SULE SL]
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NDC	71578-003-01, 71578-003-02
Set ID	5589d55f-ada5-6b80-e054-00144ff88e88
Category	HUMAN OTC DRUG LABEL
Packager	NUGGELA & SULE SL
Generic Name
Product Class
Product Number
Application Number	PART347

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ACTIVE INGREDIENTS PURPOSE

Glycerin 4.97%.................... 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
- follow the directions in the leaflet for proper use
- for better results, combine this product with Nuggela & Sule Premium shampoo and Conditioner
- follow the directions in the leaflet for proper use
- 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, PROPYLENE GLYCOL, GLYCERIN, METHYLPROPANEDIOL, CAPRYLYL GLYCOL, GLYCOGEN, POLYQUATERNIUM-11, PEG-40 HYDROGENATED CASTOR OIL, DISODIUM EDTA , PARFUm, PHENOXYETHANOL, PHENYLPROPANOL, ALLIUM CEPA BULB EXTRACT, SODIUM SUCCINATE, POTASSIUM SORBATE, SODIUM BENZOATE, SODIUM HYDROXIDE, LINALOOL, CITRAL, HEXYL CINNAMAL, LIMONENE
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

Treatment for two months

Stimulate and strenghthen the hair

With onion extract and Glycoenergizer hair

INGREDIENTS AND APPEARANCE

EFFECTIVE HAIR STRENGTHEN
glycerin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71578-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	4.97 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
LIMONENE, (+)- (UNII: GFD7C86Q1W)	0.0001 mg in 1 mL
CITRAL (UNII: T7EU0O9VPP)	0.0001 mg in 1 mL
LINALOOL, (-)- (UNII: 3U21E3V8I2)	0.0001 mg in 1 mL
WATER (UNII: 059QF0KO0R)	84.31 mg in 1 mL
CAPRYLYL GLYCOL (UNII: 00YIU5438U)	0.52 mg in 1 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.15 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
PROPANEDIOL (UNII: 5965N8W85T)	6 mg in 1 mL
PHENYLPROPANOL (UNII: 0F897O3O4M)	0.07 mg in 1 mL
ONION (UNII: 492225Q21H)	0.04 mg in 1 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)	0.005 mg in 1 mL
SODIUM BENZOATE (UNII: OJ245FE5EU)	0.005 mg in 1 mL
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)	0.0001 mg in 1 mL
SODIUM SUCCINATE HEXAHYDRATE (UNII: U16QOD6C4E)	0.01 mg in 1 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)	0.004 mg in 1 mL
METHYLPROPANEDIOL (UNII: N8F53B3R4R)	2.4 mg in 1 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71578-003-02	1 in 1 BOX	07/27/2017
1	NDC:71578-003-01	10 mL in 1 AMPULE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	07/27/2017

Labeler - NUGGELA & SULE SL (466134663)

Registrant - NUGGELA & SULE SL (466134663)

Name	Address	ID/FEI	Business Operations
Establishment
NUGGELA & SULE SL		466134663	manufacture(71578-003)

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Medic

EFFECTIVE HAIR STRENGTHEN (GLYCERIN) SOLUTION [NUGGELA & SULE SL]

WARNINGS

Warnings

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