CLEAR ITCH RELIEF- pramoxine hcl, zinc acetate spray 
TopCare

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 ingredients                                                   Purpose
Pramoxine HCI 1.0%...............................................Topical analgesic
Zinc Acetate 0.1%.....................................................Skin protectant

Purpose

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.
  • 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

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.
CLEAR SKIN PROTECTANT
Pramoxine HCl 1% - Topical Analgesic
Zinc Acetate 0.1% - Skin Protectant
Drying Action PLUS Itch Relief
Continuous Spray
Relieves Pain And Itch
Associated Wit

image description

CLEAR ITCH RELIEF 
pramoxine hcl, zinc acetate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-874
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:36800-874-0385 g in 1 CAN; Type 0: Not a Combination Product01/22/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/22/2013
Labeler - TopCare (006935977)
Registrant - Product Quest Mfg, LLC (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg, LLC927768135manufacture(36800-874) , label(36800-874)

Revised: 6/2018
Document Id: d8e45abb-2fab-4e05-b436-18b7a8e400e2
Set id: 3706db68-b671-4068-ba50-57849f66b83f
Version: 1
Effective Time: 20180625
 
TopCare