CVS ANTI ITCH- camphor, and menthol lotion

CVS ANTI ITCH by

Drug Labeling and Warnings

CVS ANTI ITCH by is a Otc medication manufactured, distributed, or labeled by CVS, Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                            Purpose

Camphor 0.5%......................................external analgesic
Menthol 0.5%....................................... external analgesic

PURPOSE

Uses
 
for the temporary relief of pain and itching associated with minor skin irritations such as
poison ivy/oak/sumac, sunburn, insect bites and minor cuts and scrapes.

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 itching associated with minor skin irritations such as
poison ivy/oak/sumac, sunburn, insect bites and minor cuts and scrapes.

WARNINGS

Warnings

For external use only

When using this product - avoid contact with the 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 of age and older:

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

Children under 2 years of age

- consult a doctor.

INACTIVE INGREDIENT

Inactive Ingredients

carbomer 940, cetyl alcohol, DMDM hydantion, fragrance, glyceryl stearate,
isopropyl myristate, PEG-8 stearate, PEG-100 stearate, petrolatum, purified water,
sodium hydroxide, stearic acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS ANTI ITCH 
camphor, and menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-713
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	5 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 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 (UNII: 92RU3N3Y1O)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
DMDM HYDANTOIN (UNII: BYR0546TOW)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POLYOXYL 100 STEARATE (UNII: YD01N1999R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-713-02	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 (062312574)

Registrant - Pharma Pac, LLC (140807475)

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