CALAMINE- ferric oxide red lotion

Calamine by

Drug Labeling and Warnings

Calamine by is a Otc medication manufactured, distributed, or labeled by DZB Brands, LLC, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

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 - 86⁰F

Inactive ingredients

bentonite magma, calcium hydroxide, glycerin, purified water

SPL UNCLASSIFIED SECTION

Distributed by: DZA Brands, LLC

Salisbury, NC 28147/Scarborough, ME 04074

For product questions or concerns

contact us at 1-866-322-2439

Made in the USA with US and foreign components

063.001/063AA

principal display panel

NDC: 55316-063-26

healthy

accents

calamine lotion

calamine topical suspension USP

skin protectant

• poison ivy
• oak
• sumac drying lotion

Net 6 FL OZ (177mL)

INGREDIENTS AND APPEARANCE

CALAMINE  
ferric oxide red lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-063
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	80 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	80 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: 55316-063-26	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/05/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/05/2008

Labeler - DZB Brands, LLC (090322194)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(55316-063)