CALAMINE PLUS PRAMOXINE HCL- calamine plus spray aerosol, spray 
Foodhold USA

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CareOne 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.

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. Intentional misuse by delibrately concentrating and inhaling 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
  • 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

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

CareOne

NO-RUB CALAMINE SPRAY

Calamine 8%/ Skin Protectant

Pramoxine HCl 1%/ External Analgesic

TEMPORARILY RELIEVES ITCHING FROM POISON IVY, OAK & SUMAC, AND INSECT BITES

SOOTHES MINOR SKIN IRRITATIONS AND CUTS

Shake well before use

NET WT 4.1 OZ (116g)

Calamine Plus Spray

CALAMINE PLUS PRAMOXINE HCL 
calamine plus spray aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-184
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24.16 mg  in 116 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE2.72 mg  in 116 g
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED0.345 mg  in 116 g
Inactive Ingredients
Ingredient NameStrength
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
ALCOHOL (UNII: 3K9958V90M)  
SORBITAN TRIOLEATE (UNII: QE6F49RPJ1)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ISOBUTANE (UNII: BXR49TP611)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-184-41116 g in 1 CANISTER; Type 0: Not a Combination Product02/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01702/01/2019
Labeler - Foodhold USA (809183973)

Revised: 1/2024
Document Id: 0ec81716-2c7f-53f1-e063-6294a90a10f5
Set id: 7cad7ad7-347a-6992-e053-2a91aa0a9ad6
Version: 4
Effective Time: 20240112
 
Foodhold USA