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NDC 55301-0063-30 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 For Your Military Exchange. The primary component is FERRIC OXIDE RED; ZINC OXIDE.

Product Information

NDC	55301-0063
Product ID	55301-063_8ada7d8a-f8d1-42f1-96d3-74503c34217e
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	8; 8
Active Ingredient Units	g/mL; mg/mL
Substance Name	FERRIC OXIDE RED; ZINC OXIDE
Labeler Name	For Your Military Exchange
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 55301-0063-30 (55301006330)

Pricing Information	N/A
NDC Package Code	55301-063-30
Billing NDC	55301006330
Package	177 mL in 1 BOTTLE, PLASTIC (55301-063-30)
Marketing Start Date	2002-10-29
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL af95a66c-f063-4019-80c6-6f7dc4fee4d8 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 Reactions

SATISFACTION GUARANTEED OR YOUR MONEY BACK

Manufactured For Your Military Exchange By:

Vi-Jon, 8515 Page Ave, St. Louis MO 63114

principal display panel

Exchange Select

CALAMINE LOTION

CALAMINE TOPICAL SUSPENSION USP

SKIN PROTECTANT

Drying lotion treats:

Poison Ivy

Poison Oak

Poison Sumac

quality value

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

CALAMINE

ferric oxide red lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55301-063
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:55301-063-30	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/29/2002

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	10/29/2002

Labeler - For Your Military Exchange (001695568)

Registrant - Vi Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon, LLC		088520668	manufacture(55301-063)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon, LLC		790752542	manufacture(55301-063)

Revised: 3/2022

Document Id: 8ada7d8a-f8d1-42f1-96d3-74503c34217e

Set id: af95a66c-f063-4019-80c6-6f7dc4fee4d8

Version: 13

Effective Time: 20220331