ITCH RELIEF CLEAR SKIN PROTECTANT CVS- pramoxine hcl, zinc acetate spray 
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%

Zinc Acetate 0.1%

Purpose

Itch Relief.

Uses

Warnings

For external use only.

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

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When using this product

  • keep out of eyes. Rinse with water to remove.
  • Do not puncture or incinerate. Contents under pressure. Do no store at temperatures above 120F.

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

SD Alcohol 38-B, Avena Sative (Oat Meal) Extract, Camphor, Citric Acid, Diazolidinyl Urea, Fragrance, Glycerin, Hypromellose, Methylparaben,Polysorbate 40, Propylene Glycol, Propylparaben, Sodium Citrate, Water.

CVS Continuous Spray Itch Relief

Clear Skin Protectant

1% Pramoxine HCl

0.1% Zinc Acetate

image description

ITCH RELIEF CLEAR SKIN PROTECTANT  CVS
pramoxine hcl, zinc acetate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-295
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:59779-295-0385 g in 1 CAN; Type 0: Not a Combination Product10/31/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/31/2014
Labeler - CVS (062312574)
Registrant - Product Quest Mfg, LLC (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg, LLC927768135manufacture(59779-295)

Revised: 11/2017
Document Id: 8456ca99-0e6f-45a4-a946-c49704e4c4ca
Set id: a90049e4-27a5-447c-8d3d-c319c3c7baf7
Version: 2
Effective Time: 20171130
 
CVS