DESIGN ESSENTIALS PEPPERMINT - ALOE THERAPEUTICS- pyrithione zinc shampoo 
.McBride Research Laboratories, Inc.

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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DESIGN ESSENTIALS PEPPERMINT & ALOE THERAPEUTICS ANTI-ITCH SHAMPOO

Active Ingredients:

Pyrithione Zinc 1%

Purpose: Antidandruff

Use: controls flaking, itching and irritation associated with dandruff and seborrheic dermatitis

Warnings:

When using this product Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Consult your physician before using this product if condition covers a large area of the body.

Stop use and consult a physician if condition worsens or does not improve after regular use.

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

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

• Wet hair, lather and massage gently into the hair and scalp.

• Rinse thoroughly and repeat if necessary.

Inactive Ingredients

Water (Aqua), Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Cocamidopropylamine Oxide, Propylene Glycol, Menthol, Mentha Piperita(Peppermint) Oil, Phenoxyethanol (and) DMDM Hydantoin (and) Iodopropnyl Butylcarbamate, Montmorillonite, Aloe Barbadensis (Aloe) Leaf Juice, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Guar Hydroxypropyltrimonium Chloride, Sodium Chloride, Citric Acid, FD& C Blue #1 (C.I. 420090), FD&C Red #33 (C.I. 17200), FD&C Yellow No.5 (C.I. 19140).


Mcbride Shampoo 8 oz

Mcbride Shampoo 32 oz

DESIGN ESSENTIALS PEPPERMINT - ALOE THERAPEUTICS 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69527-122
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MENTHOL (UNII: L7T10EIP3A)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
MONTMORILLONITE (UNII: A585MN1H2L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TEA TREE OIL (UNII: VIF565UC2G)  
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69527-122-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product01/14/2012
2NDC:69527-122-32947 mL in 1 BOTTLE; Type 0: Not a Combination Product01/14/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H01/14/2012
Labeler - .McBride Research Laboratories, Inc. (783701287)
Establishment
NameAddressID/FEIBusiness Operations
RNA PHARMA, LLC079103999manufacture(69527-122)

Revised: 1/2016
Document Id: b5d7c9e5-d0dd-42a1-acc3-5e0f477a263a
Set id: 346dbc17-ece0-46c5-8efb-2064dd0a560f
Version: 1
Effective Time: 20160120
 
.McBride Research Laboratories, Inc.