Careline by COSMOPHARM LTD. / Emilia Cosmetics Ltd Careline

Careline by

Drug Labeling and Warnings

Careline by is a Otc medication manufactured, distributed, or labeled by COSMOPHARM LTD., Emilia Cosmetics Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CARELINE  ANTI-DANDRUFF- pyrithione zinc shampoo 
COSMOPHARM LTD.

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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Careline

Active ingredients

Zinc Pyrithione 1%

Purpose

Anti Dandruff

Uses

Helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

For external use only.

Do not use

this product if you have known sensitivities to any one of the ingredients. This cosmetic product should be used only for the purpose it was intended and according to its instructions. Do not ingest.

When using this product

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

Stop use and ask a doctor

if condition worsens 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 control center immediately.

Directions:

Massage through wet hair until a rich foamy lather is obtained. Rinse off thoroughly with water.

Inactive ingredients

Water, Sodium Laureth Sulfate, Glycol Distearate, Laureth-10, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Sodium Chloride, Cocamide DEA, Parfum, Polyquaternium-10, DMDM Hydantoin, Benzophenone-4, Lactic Acid, Silk Amino Acids, Niacinamide, Calcium Phosphate, Tocopheryl Acetate, Pyridoxine HCL, Maltodextrin, Sodium Starch Octenylsuccinate, Silica, Dimethicone, Laureth-4, Laureth-23, Panthenol, Benzyl Salicylate, Hexyl Cinnamal, Limonene.

Questions?

845-501-0127

Principal Display Panel

Careline

10

Protein Silk System

SHAMPOO

For immediate softness and healthy looking hair free of dandruff

Anti-Dandruff

Net Wt. 13.5 fl oz. (400 ml) 400 gr.

NDC: 69939-165-04

CARELINE   ANTI-DANDRUFF
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69939-165
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
LAURETH-10 (UNII: BD7AST04GA)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
DMDM HYDANTOIN (UNII: BYR0546TOW)
SULISOBENZONE (UNII: 1W6L629B4K)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
AMINO ACIDS, SILK (UNII: V0L00EX1IA)
NIACINAMIDE (UNII: 25X51I8RD4)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
LAURETH-4 (UNII: 6HQ855798J)
LAURETH-23 (UNII: N72LMW566G)
PANTHENOL (UNII: WV9CM0O67Z)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69939-165-04	400 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/03/2015	09/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	09/03/2015	09/01/2019

Labeler - COSMOPHARM LTD. (600395487)

Establishment
Name	Address	ID/FEI	Business Operations
Emilia Cosmetics Ltd		600076624	manufacture(69939-165)

Revised: 8/2019

Document Id: 90b47c91-2a68-833c-e053-2a95a90acb20

34390-5

Set id: 05c04a4d-33e7-41bb-9944-f2adeb8de002

Version: 3

Effective Time: 20190822

 

COSMOPHARM LTD.