DRUG FACTS

CVS FRAGRANCE FREE ANTI-ITCH - pramoxine hydrochloride lotion
CVS Pharmacy

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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DRUG FACTS

Active ingredient Purpose

Pramoxine Hydrochloride...................................External Analgesic

Uses

For the temporary relief of itching associated with minor skin irritations

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

Uses

For the temporary relief of itching associated with minor skin irritations

Warnings

For external use only

When using this product

- avoid contact with eyes

Stop use and ask a doctor if
- condition worsens
- 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.

Directions

adults and children 2 years and older

- apply to affected area not more than 3 to 4 times daily

children under 2 years of age

- consult a doctor

Inactive Ingredients

water, isopropyl myristate, stearic acid, glyceryl stearate, PEG-100 stearate, cetyl alcohol,
PEG-8, petrolatum, dimethicone, benzyl alcohol, carbomer, sodium hydroxide

CVS FRAGRANCE FREE ANTI-ITCH
pramoxine hydrochloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-052
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 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL ALCOHOL (UNII: 936JST6JCN)
PETROLATUM (UNII: 4T6H12BN9U)
DIMETHICONE 350 (UNII: 2Y53S6ATLU)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POLYETHYLENE GLYCOL 4500 (UNII: TVH7653921)

#	Item Code	Package Description
Packaging
1	NDC:59779-052-58	80 mL in 1 BOTTLE, PUMP
2	NDC:59779-052-59	222 mL in 1 BOTTLE, PUMP

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/08/2010

Labeler - CVS Pharmacy (062312574)

Registrant - Pharma Pac, LLC (140807475)

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