OTC Medication Information: Calamine

CALAMINE- ferric oxide red and zinc oxide lotion
Vi Jon, LLC

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 — 86⁰F

Inactive ingredients

bentonite magma, calcium hydroxide, glycerin, purified water

Adverse reaction

Vi-Jon, LLC

One Swan Drive

Smyrna, TN 37167

Principal Panel Display

NDC 0869-0063-30

SWAN

Calamine

Lotion

  • Calamine topical Suspension USP
  • Skin Protectant
  • Poison Ivy, Oak, Sumac Drying Lotion

6 FL OZ (177 mL)

image descriptionimage description
CALAMINE
ferric oxide red lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0869-0063
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 80 mg in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 80 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENTONITE
CALCIUM HYDROXIDE
GLYCERIN
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0869-0063-30 177 mL in 1 BOTTLE, PLASTIC None
2 NDC:0869-0063-26 118 mL in 1 BOTTLE, PLASTIC None
3 NDC:0869-0063-34 237 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M016 07/15/1989
Labeler — Vi Jon, LLC (088520668)
Registrant — Consumer Product Partners, LLC (119091520)
Establishment
Name Address ID/FEI Operations
Consumer Product Partners, LLC 119091514 manufacture (0869-0063)

Revised: 03/2024 Vi Jon, LLC

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.

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