ITCH RELIEF CLEAR SKIN PROTECTANT CVS- pramoxine hydrochloride and zinc acetate spray 
Product Quest Mfg, LLC

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

  • Temporarily relieves pain and itching asociated with:
  • rashes due to poison ivy, poison oak or poison sumac.
  • insect bites.
  • minor skin irritation.
  • minor cuts.
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac.

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.
  • 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

  • shake well before use.
  • 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: ask a doctor. 

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 of label

ITCH RELIEF CLEAR SKIN PROTECTANT  CVS
pramoxine hcl, zinc acetate spray
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:64048-2176
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
ZINC ACETATE (ZINC CATION) ZINC ACETATE.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
AVENA SATIVA LEAF 
CAMPHOR (SYNTHETIC) 
CITRIC ACID MONOHYDRATE 
DIAZOLIDINYL UREA 
GLYCERIN 
HYDROXYMETHYL CELLULOSE 
METHYLPARABEN 
POLYSORBATE 40 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SODIUM CITRATE 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64048-2176-385 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/31/201402/13/2015
Labeler - Product Quest Mfg, LLC (927768135)
Registrant - Product Quest Mfg, LLC (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg, LLC927768135manufacture(64048-2176)

Revised: 2/2015
Document Id: b17c1e6e-b914-4727-bf2a-271b4cfd6a24
Set id: 314f562f-6e54-4cbe-8784-3be800b8350a
Version: 2
Effective Time: 20150213
 
Product Quest Mfg, LLC