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NDC 00363-0224-30 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 Walgreen Co.. The primary component is FERRIC OXIDE RED; ZINC OXIDE.

Product Information

NDC	00363-0224
Product ID	0363-0224_1c272ec5-05a8-4ec1-bf80-d07ea750b23d
Associated GPIs	48300010000510
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	Walgreen Co.
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 00363-0224-30 (00363022430)

Pricing Information	N/A
NDC Package Code	0363-0224-30
Billing NDC	00363022430
Package	177 mL in 1 BOTTLE, PLASTIC (0363-0224-30)
Marketing Start Date	1996-01-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a1efa816-792c-4f71-a473-324852574b80 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

1-888-593-0593

Disclaimer

Walgreens Pharmacist Recommended

Walgreens Pharmacist Survey Study, November 2016

adverse reactions

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL

100% SATISFACTION GUARANTEED

walgreens.com 2016 Walgreen Co

MADE IN U.S.A. WITH U.S. AND FOREIGN COMPENENTS

principal display panel

Walgreens

Calamine

Lotion

CALAMINE TOPICAL

SUSPENSION USP/

SKIN PROTECTANT

Poison ivy, oak & sumac drying lotion

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

CALAMINE

ferric oxide red lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0224
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:0363-0224-30	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/05/1996

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	01/05/1996

Labeler - Walgreen Co. (008965063)

Registrant - Vi Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon, LLC		790752542	manufacture(0363-0224)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon, LLC		088520668	manufacture(0363-0224)

Revised: 4/2022

Document Id: 1c272ec5-05a8-4ec1-bf80-d07ea750b23d

Set id: a1efa816-792c-4f71-a473-324852574b80

Version: 12

Effective Time: 20220412