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

EFFECTIVE HAIR STRENGTHEN (GLYCERIN) SOLUTION [NUGGELA & SULE SL]
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NDC	71578-004-01, 71578-004-02
Set ID	559044e1-cf42-7112-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:71578-004
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:71578-004-02	1 in 1 BOX	07/27/2017
1	NDC:71578-004-01	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(71578-004)

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Medic

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

WARNINGS

Warnings

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