CALAMINE- ferric oxide red lotion

Calamine by

Drug Labeling and Warnings

Calamine by is a Otc medication manufactured, distributed, or labeled by FOODHOLD U.S.A. LLC, Vi Jon. 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

Adverse Reaction Section

DISTRIBUTED BY FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

2016 S&S BRANDS LLC

QUALITY GUARANTEED OR YOUR MONEY BACK

063.000/063AA

principal display panel

CAREONE

Calamine

Lotion

CALAMINE TOPICAL

SUSPENSION USP

Skin Protectant

CALAMINE 8%

ZINC OXIDE 8%

POISON IVY, OAK, SUMACK

DRYING LOTION

OUR PHARMACISTS RECOMMEND

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

CALAMINE  
ferric oxide red lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-063
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	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: 41520-063-30	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/06/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/06/2013

Labeler - FOODHOLD U.S.A. LLC (809183973)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		088520668	manufacture(41520-063)