MAXIMUM STRENGTH MEDICATED ANTI-ITCH RITE AID- menthol 1 % pramoxine hydrochloride 1 % cream

MAXIMUM STRENGTH MEDICATED ANTI-ITCH by

Drug Labeling and Warnings

MAXIMUM STRENGTH MEDICATED ANTI-ITCH by is a Otc medication manufactured, distributed, or labeled by Rite Aid, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients                                     Purpose

Menthol – 1.00%                                      External Analgesic   
Pramoxine Hydrochloride – 1.00%            External Analgesic

PURPOSE

INDICATIONS & USAGE

​Uses​ For temporarily relief of pain and itching associated with: sunburn minor burns scrapes insect bites minor skin irritation  minor cuts  rashes due to poison ivy, oak & sumac

WarningsFor external use only

When using this product Avoid contact with eyes not for prolonged use

Stop use and ask a doctor if

condition worsens
symptoms persisit more than 7 days or clear up and occur again within a few days

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

Directions

• Adults and children 2 years of age and older:​ apply to the affected area no more than 4 times daily
• Children under 2 years of age: consult a doctor

Other information

Store at room temperature.

Inactive ingredients

Water, Propylene Glycol, Petrolatum, Stearyl Alcohol, Aloe Barbadensis Leaf Juice, Sodium Acrylates Copolymer, Steareth-21, Mineral Oil,
Steareth-2, Tocopheryl Acetate, Thymol, Eucalyptol, Methyl Salicylate, PPG-1 Trideceth-6, Diazolidinyl Urea, Disodium EDTA, Triethanolamine,
Iodopropynyl Butylcarbamate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH MEDICATED ANTI-ITCH  RITE AID
menthol 1 % pramoxine hydrochloride 1 % cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-7777
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	Menthol	1 g  in 100 g
Pramoxine Hydrochloride (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	Pramoxine Hydrochloride	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Propylene Glycol (UNII: 6DC9Q167V3)
Petrolatum (UNII: 4T6H12BN9U)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Steareth-21 (UNII: 53J3F32P58)
Mineral Oil (UNII: T5L8T28FGP)
Steareth-2 (UNII: V56DFE46J5)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Thymol (UNII: 3J50XA376E)
Eucalyptol (UNII: RV6J6604TK)
Methyl Salicylate (UNII: LAV5U5022Y)
PPG-1 Trideceth-6 (UNII: 1K7417JX6Q)
Diazolidinyl Urea (UNII: H5RIZ3MPW4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TROLAMINE (UNII: 9O3K93S3TK)
Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)
ACRYLAMIDE (UNII: 20R035KLCI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-7777-1	1 in 1 CARTON	05/22/2013
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/22/2013

Labeler - Rite Aid (014578892)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(11822-7777) , label(11822-7777)