ITCH RELIEF MEDICATED PADS CVS- pramoxine hcl, zinc acetate liquid 
CVS

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

Pramoxine  HCl 1%               External Analgesic

Zinc Acetate 0.1%                 Skin Pretectant

Uses

Warnings

For external use only.

Flammable: Do not use near heat, flame, or while smoking.

​​​

When using this product

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

  • condition worsens or does not improve within 7 days.
  • symptoms persist for more than 7 days or clear up and occur again with in a few days.

Keep out of reach of children

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

Directions

Inactive ingredients

Avena Sativa (Oat) Meal Extract
Camphor
Citric Acid
Diazolidinyl Urea
Fragrance
Glycerin
Hydroxypropyl Methylcellulose
Methylparaben
Polysorbate 40
Propylene Glycol
Propylparaben
SD Alcohol 38-B
Sodium Citrate
Water

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ITCH RELIEF MEDICATED PADS  CVS
pramoxine hcl, zinc acetate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-842
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
OATMEAL (UNII: 8PI54V663Y)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 40 (UNII: STI11B5A2X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-842-0369 g in 1 JAR; Type 0: Not a Combination Product03/15/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/15/2017
Labeler - CVS (062312574)
Registrant - Product Quest Mfg, LLC (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg, LLC927768135manufacture(69842-842)

Revised: 11/2017
Document Id: ee0481a3-7cd0-488d-88c5-1654fbad4869
Set id: 3ea8d699-db55-47bf-ade7-6f3e443dfae5
Version: 2
Effective Time: 20171130
 
CVS