Rite Aid Soothing Medicated Anit-Itch

Dosage form: cream
Ingredients: PRAMOXINE HYDROCHLORIDE 10mg in 1g, MENTHOL 10mg in 1g
Labeler: RITE AID CORPORATION
NDC Code: 11822-0415

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.

DRUG FACTS

Active ingredient                                 Purpose

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



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. If swallowed, get medical help or contact a
Poison Control Center right away.


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

- 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.


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 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




RITE AID SOOTHING MEDICATED ANIT-ITCH 
menthol, pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0415
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
MENTHOL (MENTHOL) MENTHOL10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
STEARYL ALCOHOL 
PETROLATUM 
PROPYLENE GLYCOL 
ALOE VERA LEAF 
TRIDECETH-6 
STEARETH-21 
STEARETH-2 
THYMOL 
ALPHA-TOCOPHEROL 
METHYL SALICYLATE 
EDETATE DISODIUM 
DIAZOLIDINYL UREA 
TROLAMINE 
IODOPROPYNYL BUTYLCARBAMATE 
PROPYLENE GLYCOL 
EUCALYPTUS OIL 
Packaging
#Item CodePackage Description
1NDC:11822-0415-11 TUBE (TUBE) in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/08/2010
Labeler - RITE AID CORPORATION (014578892)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIOperations
Pharma Pac, LLC140807475manufacture

Revised: 07/2010
 
RITE AID CORPORATION

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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