OTC Medication Information: Calamine

CALAMINE- ferric oxide red and zinc oxide lotion
Preferred Pharmaceuticals Inc.

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

Questions or comments?

(800) 616-2471

Adverse reactions

Distributed By:

MAJOR PHARMACEUTICALS

17177 N LAUREL PARK DRIVE, SUITE 233

Livonia, MI 48152

Re-Order No 014282 M-97

Rev. 10/16

principal display panel

NDC 68788-0292-1

MAJOR

Calamine

Lotion

Calamine Topical Suspension USP

Skin Protectant

Poison Ivy, Oak, Sumac

Drying Lotion

Shake well before using

6 FL OZ (177 mL)

Calamine Lotion
(click image for full-size original)
CALAMINE
ferric oxide red lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-0292(NDC:0904-2533)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FERRIC OXIDE RED (FERRIC OXIDE RED) FERRIC OXIDE RED 8 g in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 8 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENTONITE
CALCIUM HYDROXIDE
GLYCERIN
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-0292-1 177 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug 347 04/19/2018
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 RELABEL (68788-0292)

Revised: 03/2024 Preferred Pharmaceuticals Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2024. All Rights Reserved.