CALAMINE PLUS- calamine plus pramoxine hcl aerosol, spray 
Meijer Distribution 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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Meijer Calamine Plus Spray

Active ingredients

Calamine 8%

Pramoxine HCI 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 temperatures above 120°F. Intentional misuse by deliberately 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

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again in a few days

Keep out of the 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

meijer

NO-RUB

calamine plus spray

Calamine 8%/Skin Protectant

Pramoxine HCI 1%/External analgesic

Relieves itching from poison ivy, oak & sumac, & insect bites

Soothes minor skin irritations & cuts

SHAKE WELL BEFORE USE

NET WT 4.1 OZ (116 g)

image 1

CALAMINE PLUS 
calamine plus pramoxine hcl aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-0615
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED5 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE79.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
ISOBUTANE (UNII: BXR49TP611)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
SORBITAN TRIOLEATE (UNII: QE6F49RPJ1)  
ALCOHOL (UNII: 3K9958V90M)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79481-0615-1116 g in 1 CANISTER; Type 0: Not a Combination Product08/25/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/25/2023
Labeler - Meijer Distribution Inc. (006959555)

Revised: 8/2023
Document Id: 03c4ab8f-7182-914c-e063-6394a90aee27
Set id: 03c46823-0b1f-4101-e063-6294a90aaf94
Version: 1
Effective Time: 20230825
 
Meijer Distribution Inc.