Calamine Plus Spray

Calamine Plus Spray

Drug Labeling and Warnings

Drug Details

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CALAMINE PLUS PRAMOXINE HCL- calamine plus spray aerosol, spray 
Topco Associates 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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Calamine Plus Spray

Active ingredient

Calamine 8%
Pramoxine HCl 1%

Purpose

Skin protectant
External analgesic

Uses

temporarily relieves pain and itching associated with:

  • insect bites
  • rashes
  • minor skin irritations
  • minor cuts
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings

For external use only. 

Flammable:

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF

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
  • symptoms 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

  • shake well before using
  • adults and children 2 years of age and older: apply as needed to the affected area, not more than 3 or 4 times daily
  • cleanse the skin with soap and water
  • let dry before use
  • children under 2 years of age: consult a doctor

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 1-888-423-0139

Principal Display Panel

TopCare Health

NO RUB

Calamine Plane Spray

Calamine 8% - Skin Protectant

Promoxine HCL 1% - External Analgesic

Itch Relief from:

poison ivy/ oak/ sumac

insect bites,

Soothes minor skin irritations

SHAKE WELL BEFORE USE

NET WT 4.1 OZ (116 g)

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Top Care_Calamine Lotion Spray_50-074TC-04 12.24.01 PM.jpg

Top Care_Calamine Lotion Spray_50-074TC-04 12.24.01 PM.jpg

Top Care_Calamine Lotion Spray_50-074TC-04 12.24.01 PM.jpg

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 not finalpart34801/01/2017
Labeler - Topco Associates LLC (006935977)

Revised: 11/2018
 
Topco Associates LLC


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