CALAMINE - ferric oxide red lotion
FOODHOLD U.S.A. LLC

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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Care One 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 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)

image description

CALAMINE
ferric oxide red lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41520-063
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:41520-063-30	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/06/2013	09/18/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	02/06/2013	09/18/2023

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

Registrant - Vi Jon (790752542)

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

Revised: 9/2023

Document Id: f3dc2e01-cc3f-4c66-86e2-ef43d60b6eea

Set id: 261e4092-c986-488e-b8cf-e754a6403af7

Version: 8

Effective Time: 20230918

FOODHOLD U.S.A. LLC