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← See all Calamine Plus Pramoxine HCl brands

Calamine Plus Pramoxine HCl by Topco Associates LLC

Dosage form: aerosol, spray
Ingredients: FERRIC OXIDE RED 0.345mg in 116g, ZINC OXIDE 24.16mg in 116g, PRAMOXINE HYDROCHLORIDE 2.72mg in 116g
Labeler: Topco Associates LLC
NDC Code: 36800-398

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.

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.

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: 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 1-866-964-0939

Principal Display Panel

TopCare

NO TOUCH

Calamine Plane 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 PLUS PRAMOXINE HCL 
calamine plus spray aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-398
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC OXIDE RED (FERRIC OXIDE RED) FERRIC OXIDE RED0.345 mg  in 116 g
ZINC OXIDE (ZINC CATION) ZINC CATION24.16 mg  in 116 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE2.72 mg  in 116 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
CAMPHOR (SYNTHETIC) 
DISTEARDIMONIUM HECTORITE 
HYDRATED SILICA 
ISOBUTANE 
OLEYL ALCOHOL 
ALCOHOL 
SORBITAN TRIOLEATE 
Packaging
#Item CodePackage Description
1NDC:36800-398-41116 g in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2017
Labeler - Topco Associates LLC (006935977)

 
Topco Associates LLC

← See all Calamine Plus Pramoxine HCl brands

Medically reviewed on Dec 2, 2017

Further information

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

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