CALAMINE PLUS PRAMOXINE HCL- calamine plus spray aerosol, spray 
HY-VEE, INC

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:

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

HyVee Health 

Calamine Plan 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)

Hyvee_Calamine Spray_50-074HY-01.jpg

CALAMINE PLUS PRAMOXINE HCL 
calamine plus spray aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-147
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:42507-147-41116 g in 1 CANISTER; Type 0: Not a Combination Product12/22/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/22/2017
Labeler - HY-VEE, INC (006925671)

Revised: 12/2017
Document Id: 4ba77efb-690f-4e52-8907-fa2d9159052f
Set id: 7a5475ae-f2df-4bbe-aca1-635f719a088a
Version: 1
Effective Time: 20171222
 
HY-VEE, INC