CALAMINE - ferric oxide red lotion
Hy-Vee, 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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Hy Vee 063.001-063AA

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

Adverse Reaction Section

DISTRIBUTED BY HY-VEE, INC.

5820 WESTOWN PARKWAY

WEST DES MOINES, IA 50266

SATISFACTION GUARANTEED OR PURCHASE PRICE REFUNDED

FOR INFORMATION CALL 1-800-289-8343

www.hy-vee.com

063.001/063AA

principal display panel

HY-VEE

Calamine

Lotion

Calamine topical

suspension USP

skin protectant

Poison Ivy, Oak, Sumac Drying Lotion

6 FL OZ (177mL)

image description

CALAMINE
ferric oxide red lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42507-063
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 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:42507-063-30	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/15/1998	06/26/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	08/15/1998	06/26/2020

Labeler - Hy-Vee, Inc (006925671)

Registrant - Vi Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon		790752542	manufacture(42507-063)

Revised: 6/2020

Document Id: bd08b7c3-eaeb-4853-bf78-8c71a5a914f3

Set id: fbae0fb5-3e83-4f32-9c08-28a7c7b1c3b6

Version: 7

Effective Time: 20200626

Hy-Vee, Inc