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NDC 41190-0063-30 Calamine 80; 80 mg/mL; mg/mL Details

Calamine 80; 80 mg/mL; mg/mL

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

Product Information

NDC	41190-0063
Product ID	41190-063_fc0218d7-2776-450e-a694-556d637050e3
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
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	80; 80
Active Ingredient Units	mg/mL; mg/mL
Substance Name	FERRIC OXIDE RED; ZINC OXIDE
Labeler Name	Wakefern Food Corp
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 41190-0063-30 (41190006330)

Pricing Information	N/A
NDC Package Code	41190-063-30
Billing NDC	41190006330
Package	177 mL in 1 BOTTLE, PLASTIC (41190-063-30)
Marketing Start Date	1989-07-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 75d27726-68b5-4b2a-b374-03ae059ee5fc 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

Adverse Reaction Section

DISTRIBUTED BY

WAKEFERN FOOD CORP.

5000 RIVERSIDE DRIVE

KEASBEY, NJ 08832

principal display panel

ShopRite

SKIN PROTECTANT

CALAMINE

LOTION

CALAMINE TOPICAL SUSPENSION U.S.P.

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:41190-063
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	80 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	80 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:41190-063-30	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/1989

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	07/15/1989

Labeler - Wakefern Food Corp (069722418)

Registrant - Vi Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon, LLC		790752542	manufacture(41190-063)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon, LLC		088520668	manufacture(41190-063)

Revised: 4/2022

Document Id: fc0218d7-2776-450e-a694-556d637050e3

Set id: 75d27726-68b5-4b2a-b374-03ae059ee5fc

Version: 13

Effective Time: 20220407