ANTIDANDRUFF- pyrithione zinc shampoo 
BBCOS S.R.L.

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.

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GREEN CARE ESSENCE ANTI-DANDRUFF SHAMPOO
These highlights do not include all the information needed to use see full prescribing information for Initial U.S. Approval

Active Ingredient:

Pyrithione Zinc 1%

Uses:

Fights and helps prevents recurrence of flacking and itching associated with dandruff

Warnings:

For external use only.

When using this product:

avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop using this product and consult a doctor:

if conditions worsen or does not improve after regular use of this product as directed.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Center immediately.

Directions:

For best results use at least twice a week or as directed by a dcoctor.

Apply shampoo, massaging it thoroughly into the scalp. Rinse and repeat.

Professional product.

Inactive ingredients:

AQUA (WATER), SODIUM LAURETH SULFATE, SODIUM CHLORIDE, COCAMIDOPROPYL BETAINE, GLYCERIN, LAURAMIDOPROPYL BETAINE, PROPYLENE GLYCOL, SODIUM PCA, PEG-7 GLYCERYL COCOATE, PEG-200 HYDROGENATED GLYCERYL PALMATE, PARFUM (FRAGRANCE), BENZYL ALCHOL, POTASSIUM SORBATE, SODIUM BENZOATE, PEG-40 HYDROGENATED CASTOR OIL, TETRASODIUM EDTA, SALVIA OFFICINALIS (SAGE) LEAF EXTRACT, URTICA DIOICA (NETTLE) LEAF EXTRACT, MENTHA PIPERITA (MINT) EXTRACT, PEG/PPG-14/4 DIMETHICONE, PIROCTONE OLAMINE, CITRIC ACID, PANTHENOL, MENTHOL

artworkGREEN

CARE

ESSENCE

ANTI-DANDRUFF

SHAMPOO

SAGE NETTLE MINT

PYRITHIONE ZINC

ANTIDANDRUFF 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70549-123
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  in 1000 mg
Inactive Ingredients
Ingredient NameStrength
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLYCERIN (UNII: PDC6A3C0OX)  
LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
PEG-200 HYDROGENATED GLYCERYL PALMATE (UNII: W161T051Y1)  
EDETATE SODIUM (UNII: MP1J8420LU)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PEG/PPG-14/4 DIMETHICONE (UNII: 646XNV22YX)  
PIROCTONE OLAMINE (UNII: A4V5C6R9FB)  
PANTHENOL (UNII: WV9CM0O67Z)  
MENTHOL (UNII: L7T10EIP3A)  
SAGE (UNII: 065C5D077J)  
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)  
MENTHA PIPERITA (UNII: 79M2M2UDA9)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize3mm
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70549-123-111000 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2016
2NDC:70549-123-22250 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2016
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H06/01/2016
Labeler - BBCOS S.R.L. (434126395)

Revised: 5/2016
Document Id: 332e40fb-70a4-2e4f-e054-00144ff8d46c
Set id: 332e40fb-70a3-2e4f-e054-00144ff8d46c
Version: 1
Effective Time: 20160519
 
BBCOS S.R.L.