CVS FRAGRANCE FREE ANTI-ITCH- pramoxine hydrochloride lotion

CVS Fragrance Free Anti-Itch by

Drug Labeling and Warnings

CVS Fragrance Free Anti-Itch by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                 Purpose

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

PURPOSE

Uses

For the temporary relief of itching associated with minor skin irritations

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 itching associated with minor skin irritations

WARNINGS

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - CVS Pharmacy (062312574)

Registrant - Pharma Pac, LLC (140807475)

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