CALAMINE PLUS PRAMOXINE HCL- calamine plus no touch spray aerosol, spray 
Premier Brands of America Inc.

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Premier Brands Calamine Plus

Active ingredient

Calamine 8%
Pramoxine HCl 1%

Purpose

Skin protectant
External analgesic

Uses

temporarily relieves pain and itching associated with:

​Warnings

​For external use only. ​ Use only as directed. Intentional misuse by deliberately concentrating and inhailing contents can be harmful or fatal.

​Flammable:

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

​When using this product

  • do not get into eyes
  • ask a doctor before  using on children under 2 years of age

Stop use and ask a doctor if

  • conditions worsens
  • symtomps last more than 7 days or clear up and occur again in a few days

​Keep out of reach of children.

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

Directions

​Other information

store between 20° to 25°C (68° to 77°F)

​Inactive ingredients

benzyl alcohol, camphor, disteardimonium hectorite, fragrance, hydrated silica, isobutane, oleyl alcohol, SD alcohol 40-B, sorbitan trioleate

​Questions?

Call 1-866-964-0939

Principal Display Panel

Premier
Calamine Plus
No-Touch Spray

Shake well before using

6.0 FL OZ (177mL)
Net Wt 4.1 OZ (116g)

PB Calamine Spray.jpg

CALAMINE PLUS PRAMOXINE HCL 
calamine plus no touch spray aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-031
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED0.345 mg  in 177 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24.16 mg  in 177 mL
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE2.72 mg  in 177 mL
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
ISOBUTANE (UNII: BXR49TP611)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SORBITAN TRIOLEATE (UNII: QE6F49RPJ1)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56104-031-41177 mL in 1 CANISTER; Type 0: Not a Combination Product01/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01701/01/2013
Labeler - Premier Brands of America Inc. (063849780)

Revised: 10/2024
Document Id: 23e706d3-5cb8-fb10-e063-6394a90ac2e7
Set id: 8ec89d0e-c921-47d3-9b20-cdf403dc66cf
Version: 8
Effective Time: 20241007
 
Premier Brands of America Inc.