CALAMINE- ferric oxide red lotion
Preferred Pharmaceuticals 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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Drug Facts

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

063.001/063AA

Relabeled By: Preferred Pharmaceuticals Inc.

Principal Display Panel

NDC 68788-0902-1

MAJOR

Relabeled By: Preferred Pharmaceuticals Inc.

Calamine

Lotion

Calamine Topical Suspension USP

Skin Protectant

Poison Ivy, Oak, Sumac

Drying Lotion

Shake well before using

6 FL OZ (177 mL)

CALAMINE
ferric oxide red lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68788-0292(NDC:0904-2533)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)	FERRIC OXIDE RED	8 g in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	8 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENTONITE (UNII: A3N5ZCN45C)
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68788-0292-1	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/19/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	04/19/2018

Labeler - Preferred Pharmaceuticals Inc. (791119022)

Registrant - Preferred Pharmaceuticals Inc. (791119022)

Name	Address	ID/FEI	Business Operations
Establishment
Preferred Pharmaceuticals Inc.		791119022	RELABEL(68788-0292)

Revised: 1/2021

Document Id: 4209c0c4-89bd-43c3-bc2d-801d5e7309f3

Set id: 326f3d80-c1bf-4cf0-a662-58e02ed7ee67

Version: 3

Effective Time: 20210111

Preferred Pharmaceuticals Inc.