CALAMINE- ferric oxide red lotion

Calamine by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients

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 wthin 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

SPL UNCLASSIFIED SECTION

Visit us at: Rexall.com

or call 1-866-4REXALL

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072 USA

063.001/063AA

principal display panel

Since 1903
REXALL

Calamine Lotion
Calamine Topical Suspension USP
Poison ivy, oak and sumac drying lotion
Skin protectant

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

CALAMINE  
ferric oxide red lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-063
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: 55910-063-30	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/13/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/13/2009

Labeler - Dolgencorp, LLC (068331990)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		790752542	manufacture(55910-063)