CALAMINE - ferric oxide red lotion
Perrigo Direct, Inc.

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Calamine Lotion
063.001/063AA

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 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

Distributed by: Perrigo Direct, Inc

Peachtree City, GA 30269

www.PerrigoDirect.com

1-866-593-0593

GoodSense is a registered trademark of L. Perrigo Company.

principal display panel

GOODSENSE

Calamine Lotion

Calamine Topical Suspension USP

Skin Protectant

Poison Ivy, Oak, Sumac, Drying Lotion

6 FL OZ (177 mL)

image description

CALAMINE
ferric oxide red lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50804-063
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 mg 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:50804-063-30	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/1992	10/16/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	09/15/1992	10/16/2023

Labeler - Perrigo Direct, Inc. (076059836)

Registrant - Vi Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon, LLC		790752542	manufacture(50804-063)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon, LLC		088520668	manufacture(50804-063)

Revised: 10/2023

Document Id: 518d6789-2e89-447b-9168-ac825832086c

Set id: 63f45b6a-115e-45f6-ad5c-0ef20623763e

Version: 15

Effective Time: 20231016

Perrigo Direct, Inc.

Calamine Lotion063.001/063AA