CALAMINE- ferric oxide red lotion 
Preferred Pharmaceuticals Inc.

----------

Major 063.001  063AA

Active ingredents

Calamine 8%
Zinc oxide 8%

Purpose

Skin Protectant

Use

dries the oozing and weeping of poison:•ivy • oak • sumac

Warnings

For external use only

When using this product

Do not get into eyes

Stop use and ask a doctor if

•
condition worsens
•
symptoms last more than 7 days or clear up and occur again within 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 
•
apply as needed

Other information

store at 59⁰ - 86⁰ F

Inactive ingredients

bentonite magma, calcium hydroxide, glycerin, purified water

Questions or comments?

(800) 616-2471

Adverse reactions

Distributed By:

MAJOR PHARMACEUTICALS

17177 N LAUREL PARK DRIVE, SUITE 233

Livonia, MI 48152

Re-Order No 014282  M-97

Rev. 10/16

principal display panel

NDC 68788-0292-1

MAJOR

Calamine

Lotion

Calamine Topical Suspension USP

Skin Protectant

Poison Ivy, Oak, Sumac

Drying Lotion

Shake well before using

6 FL OZ (177 mL)

Calamine Lotion
CALAMINE 
ferric oxide red lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-0292(NDC:0904-2533)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED8 g  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE8 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENTONITE (UNII: A3N5ZCN45C)  
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-0292-1177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/19/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug34704/19/2018
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-0292)

Revised: 3/2024
Document Id: b74458fe-4c1b-43ec-a61e-a8380cab910a
Set id: 326f3d80-c1bf-4cf0-a662-58e02ed7ee67
Version: 5
Effective Time: 20240315
 
Preferred Pharmaceuticals Inc.