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Calamine Plus Pramoxine HCl by Premier Brands of America Inc.

Medically reviewed on Nov 9, 2017

Dosage form: aerosol, spray
Ingredients: FERRIC OXIDE RED 0.345mg in 177mL, ZINC OXIDE 24.16mg in 177mL, PRAMOXINE HYDROCHLORIDE 2.72mg in 177mL
Labeler: Premier Brands of America Inc.
NDC Code: 56104-031

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.

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

​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

  • External analgesic & skin protectant
  • Drying action plus itch relief
  • Ideal for poison ivy/oak/sumac, insect bites, minor skin irritations & cuts

Shake well before using

6.0 FL OZ (177mL)

Net Wt 4.1 OZ (116g)

CALAMINE PLUS PRAMOXINE HCL 
calamine plus no touch spray aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-031
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC OXIDE RED (FERRIC OXIDE RED) FERRIC OXIDE RED0.345 mg  in 177 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE24.16 mg  in 177 mL
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE2.72 mg  in 177 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
CAMPHOR (SYNTHETIC) 
HYDRATED SILICA 
ISOBUTANE 
OLEYL ALCOHOL 
SORBITAN TRIOLEATE 
DISTEARDIMONIUM HECTORITE 
ALCOHOL 
Packaging
#Item CodePackage Description
1NDC:56104-031-41177 mL in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2013
Labeler - Premier Brands of America Inc. (080051232)

 
Premier Brands of America Inc.

← See all Calamine Plus Pramoxine HCl brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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