Cvs Medicated Anti-Itch (Menthol, Pramoxine Hydrochloride) Cream [Cvs Pharmacy] -

CVS MEDICATED ANTI-ITCH (MENTHOL, PRAMOXINE HYDROCHLORIDE) CREAM [CVS PHARMACY]
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NDC	59779-621-64
Set ID	01447a2d-3a6a-4947-80cf-570b0a2941dd
Category	HUMAN OTC DRUG LABEL
Packager	CVS Pharmacy
Generic Name
Product Class
Product Number
Application Number	PART347

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ACTIVE INGREDIENT

Active ingredient Purpose

Menthol 1%....................................................Anti-Itch Pain Relief
Pramoxine Hydrochloride 1%............................Anti-Itch Pain Relief
PURPOSE

Uses

For the temporary relief of pain and discomfort cause by
- minor burns - sunburn - scrapes - insect bites
- minor skin irritations - rashes due to poison ivy, oak and sumac
KEEP OUT OF REACH OF CHILDREN

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

Uses

For the temporary relief of pain and discomfort cause by
- minor burns - sunburn - scrapes - insect bites
- minor skin irritations - rashes due to poison ivy, oak and sumac
WARNINGS

Warnings

For external use only

Do Not use - under bandages or compresses

When using this product

- avoid contact with the eyes

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

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

Directions

- Adults and children 2 years and older: apply to affected area not more than 2 tim

- Children under 2 years of age: do not use, consult a doctor
INACTIVE INGREDIENT

Inactive Ingredients

Water, Propylene Glycol, Petrolatum, Stearyl Alcohol, Aloe Barbadensis Gel, Sodium Acrylates Copolymer, Mineral Oil, Steareth 21, PPG 1 Trideceth, 6, Toco[heryl Acetate, Disodium EDTA, Methyl Salicylate, Thymol, Eucalyptol, Triethanolamine, Iodopropynyl Butylcarbamate, Diozolidinyl Urea
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS MEDICATED ANTI-ITCH
menthol, pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-621
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
STEARETH-21 (UNII: 53J3F32P58)
STEARETH-2 (UNII: V56DFE46J5)
THYMOL (UNII: 3J50XA376E)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
METHYL SALICYLATE (UNII: LAV5U5022Y)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
TROLAMINE (UNII: 9O3K93S3TK)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EUCALYPTUS OIL (UNII: 2R04ONI662)

#	Item Code	Package Description
Packaging
1	NDC:59779-621-64	1 in 1 CARTON
1		56 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	07/08/2010

Labeler - CVS Pharmacy (062312574)

Registrant - Pharma Pac, LLC (140807475)

Name	Address	ID/FEI	Business Operations
Establishment
Pharma Pac, LLC		140807475	manufacture

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