OTC Medication Information: Calamine

CALAMINE- ferric oxide red and zinc oxide lotion
Topco Associates LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

DIST.BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

1-888-423-0139 TOPCO VIJ 712

topcare@topco.com

063.001/063AA

principal display panel

NDC 36800-063-30

TOPCARE

Calamine

Lotion

CALAMINE TOPICAL

SUSPENSION USP

SKIN PROTECTANT

POISON IVY, OAK SUMAC DRYING LOTION

6 FL OZ (177 mL)

image description
(click image for full-size original)
CALAMINE
ferric oxide red lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-063
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:36800-063-30 177 mL in 1 BOTTLE, PLASTIC None
2 NDC:36800-063-26 237 mL in 1 BOTTLE, PLASTIC None
3 NDC:36800-063-34 237 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 09/15/1991
Labeler — Topco Associates LLC (006935977)
Registrant — Vi Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi Jon, LLC 790752542 manufacture (36800-063)

Revised: 04/2021 Topco Associates 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.

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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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