DESIGN ESSENTIALS PEPPERMINT - ALOE THERAPEUTICS- pyrithione zinc shampoo

DESIGN ESSENTIALS PEPPERMINT - ALOE THERAPEUTICS by

Drug Labeling and Warnings

DESIGN ESSENTIALS PEPPERMINT - ALOE THERAPEUTICS by is a Otc medication manufactured, distributed, or labeled by .McBride Research Laboratories, Inc., RNA PHARMA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Pyrithione Zinc 1%

PURPOSE

Purpose: Antidandruff

INDICATIONS & USAGE

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

WARNINGS

Warnings:

• For external use only.

WHEN USING

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

ASK DOCTOR

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

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

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).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DESIGN ESSENTIALS PEPPERMINT - ALOE THERAPEUTICS 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69527-122
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69527-122-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/14/2012
2	NDC: 69527-122-32	947 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/14/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/14/2012

Labeler - .McBride Research Laboratories, Inc. (783701287)

Establishment
Name	Address	ID/FEI	Business Operations
RNA PHARMA, LLC		079103999	manufacture(69527-122)