CALAMINE PLUS PRAMOXINE HCL- calamine plus spray aerosol, spray 
Topco Associates LLC

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TopCare Calamine Plus Spray

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.

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

TopCare

NO TOUCH

Calamine Plus Spray

Calamine 8% - Skin Protectant

Promoxine HCL 1% - External Analgesic

Drying action plus itch relief

Ideal for: poison ivy/oak/sumac

insect bites, minor skin irritations & cuts

SHAKE WELL BEFORE USE

NET WT 4.1 OZ (116 g)

calamine

CALAMINE PLUS PRAMOXINE HCL 
calamine plus spray aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-398
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 116 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION24.16 mg  in 116 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE2.72 mg  in 116 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
ISOBUTANE (UNII: BXR49TP611)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
ALCOHOL (UNII: 3K9958V90M)  
SORBITAN TRIOLEATE (UNII: QE6F49RPJ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-398-41116 g in 1 CANISTER; Type 0: Not a Combination Product01/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01701/01/2017
Labeler - Topco Associates LLC (006935977)

Revised: 2/2024
Document Id: 10cfdf41-e516-ccba-e063-6294a90a980f
Set id: af314adb-bd65-4233-b7e1-6cfb819615a3
Version: 9
Effective Time: 20240207
 
Topco Associates LLC