FIRST AID SENSITIVE ANTI-ITCH- pramoxine hydrochloride 1.0% lotion 
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 ingredient                                   Purpose
Pramoxine Hydrochloride 1.0%.............External Analgesic

Uses

For temporary relief of pain and itching associated with
• minor burns • sunburn • minor cuts • scrapes • insect bites
• minor skin irritations

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.

Directions
• To open, squeeze cap tightly and turn pump counter-clockwise. • Adults and
children 2 years of age and older: Apply to affected area not more than 3 to 4
times daily. • Children under 2 years of age: Consult a doctor

Inactive ingredients

Aloe Barbadensis Leaf Juice
Carbomer
Cetyl Alcohol
Chamomilla Recutita (Matricaria) Flower Extract
Ethylhexylglycerin
Glyceryl Stearate
Isopropyl Myristate
PEG-100 Stearate
PEG-8 Stearate
Petrolatum
Phenoxyethanol
Sodium Hydroxide
Stearic Acid
Water

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FIRST AID SENSITIVE ANTI-ITCH 
pramoxine hydrochloride 1.0% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-1236
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pramoxine Hydrochloride (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) Pramoxine Hydrochloride1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
Cetyl Alcohol (UNII: 936JST6JCN)  
CHAMOMILE (UNII: FGL3685T2X)  
Ethylhexylglycerin (UNII: 147D247K3P)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
Isopropyl Myristate (UNII: 0RE8K4LNJS)  
PEG-100 Stearate (UNII: YD01N1999R)  
PEG-8 Stearate (UNII: 2P9L47VI5E)  
Petrolatum (UNII: 4T6H12BN9U)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-1236-6222 mL in 1 BOTTLE; Type 0: Not a Combination Product12/31/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/31/2012
Labeler - Rite Aid (014578892)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(11822-1236) , label(11822-1236)

Revised: 6/2018
Document Id: 59ad278a-af21-4049-874a-624751fed57a
Set id: 989201ae-e09b-4f15-9a44-d48b09933150
Version: 1
Effective Time: 20180619
 
Rite Aid