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NDC 00904-2533-21 Calamine 8; 8 g/mL; mg/mL Details

Calamine 8; 8 g/mL; mg/mL

Calamine is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Major Pharmaceuticals. The primary component is FERRIC OXIDE RED; ZINC OXIDE.

Product Information

NDC	00904-2533
Product ID	0904-2533_8a532bb2-117d-4b42-a4a9-768af4e44e45
Associated GPIs	90979902204100
GCN Sequence Number	061802
GCN Sequence Number Description	calamine/zinc oxide LOTION 8 %-8 % TOPICAL
HIC3	L3A
HIC3 Description	PROTECTIVES
GCN	97587
HICL Sequence Number	002304
HICL Sequence Number Description	CALAMINE/ZINC OXIDE
Brand/Generic	Generic
Proprietary Name	Calamine
Proprietary Name Suffix	n/a
Non-Proprietary Name	FERRIC OXIDE RED
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	8; 8
Active Ingredient Units	g/mL; mg/mL
Substance Name	FERRIC OXIDE RED; ZINC OXIDE
Labeler Name	Major Pharmaceuticals
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00904-2533-21 (00904253321)

Pricing Information
NDC Package Code	0904-2533-21
Billing NDC	00904253321
Package	177 mL in 1 BOTTLE, PLASTIC (0904-2533-21)
Marketing Start Date	2013-01-07
NDC Exclude Flag	N
Price Per Unit	0.00933
Pricing Unit	ML
Effective Date	2024-01-17
NDC Description	CALAMINE LOTION
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL c25be68d-834a-4959-8d47-01ec789406ba Details

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 0904-2533-21

MAJOR

Calamine

Lotion

Calamine Topical Suspension USP

Skin Protectant

Poison Ivy, Oak, Sumac

Drying Lotion

Shake well before using

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

CALAMINE

ferric oxide red lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-2533
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:0904-2533-21	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/07/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	01/07/2013

Labeler - Major Pharmaceuticals (191427277)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(0904-2533)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(0904-2533)

Revised: 4/2022

Document Id: 8a532bb2-117d-4b42-a4a9-768af4e44e45

Set id: c25be68d-834a-4959-8d47-01ec789406ba

Version: 11

Effective Time: 20220405