CALAMINE- ferric oxide red lotion

Calamine by

Drug Labeling and Warnings

Calamine by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, Vi-Jon, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

principal display panel

NDC: 0904-2533-21

MAJOR

Calamine

Lotion

Calamine Topical Suspension USP

Skin Protectant

Poison Ivy, Oak, Sumac

Drying Lotion

Shake well before using

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

CALAMINE 
ferric oxide red lotion

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-2533-21	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/07/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	01/07/2013

Labeler - Major Pharmaceuticals (191427277)

Registrant - Vi-Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc		790752542	manufacture(0904-2533)