RITE AID SOOTHING MEDICATED ANIT-ITCH- menthol, pramoxine hydrochloride cream

Rite Aid Soothing Medicated Anit-Itch by

Drug Labeling and Warnings

Rite Aid Soothing Medicated Anit-Itch by is a Otc medication manufactured, distributed, or labeled by RITE AID CORPORATION, Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                 Purpose

Menthol 1%....................................................Pain Reliever
Pramoxine Hydrochloride 1%............................External Analgesic

PURPOSE

Uses

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

WARNINGS

Warnings

- For external use only
- Avoid contact with the eyes

Do Not use - under bandages or compresses

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 times daily

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

Other information

Store at room temperature. Lot No. and Exp. Date: see crimp of tube or see box.

INACTIVE INGREDIENT

Inactive Ingredients

aloe barbadensis leaf juice, diazolidinyl urea, disodium EDTA, eucalyptus globules leaf oil, iodopropynyl butylcarbamate, methyl salicylate,
petrolatum, PPG-1 trideceth-6, propylene glycol, purified water, sodium acrylates copolymer, steareth-2 steareth-21, stearyl alcohol, thymol,
tocopheryl acetate, triethanolamine

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RITE AID SOOTHING MEDICATED ANIT-ITCH 
menthol, pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-0415
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 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-0415-1	1 in 1 CARTON
1		28 g in 1 TUBE

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

Labeler - RITE AID CORPORATION (014578892)

Registrant - Pharma Pac, LLC (140807475)

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