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

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 ingredients Purpose

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

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

Warnings
For 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

image description

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/22/2013

Labeler - Rite Aid (014578892)

Registrant - Product Quest Mfg (927768135)

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