OTC Medication Information: Calamine

CALAMINE- zinc oxide lotion
Pierson Laboratories

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.

Drug Facts

Active Ingredients

Calamine 8% and Zinc Oxide 8%

Purpose

Skin protectant

Uses

dries the oozing and weeping o poison ivy, poison oak, and poison sumac.

Warnings

For external use only. Use only as directed.

Avoid contact with eyes and mucous membranes.

Ask a doctor before using on chilren 6 months of age.

When using this product

Discontinue use if condition worsens or does not improve within 7 days and consult a doctor.

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or contact a Poison Control center immediately.

Directions

Adults and chidren 2 years of age and older: shake well before using. Cleanse the skin with soap and water and let it dry befroe each use. Apply lotion to the affected area using a cotton or soft cloth, as often as needed for comfort.

Children under 6 months of age: Consult a doctor before use.

Other information

Store at room temperature 13-30C (50-86F)

Inactive ingredients

Bentonite magma, calcium hydroxide, glycerin, purified water.

Label

Label
(click image for full-size original)

CALAMINE
calamine 8% and zinc oxide 8% lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:45591-041
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC CATION) ZINC CATION 160 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENTONITE
CARRAGEENAN
XANTHAN GUM
CALCIUM HYDROXIDE
GLYCERIN
WATER
MICROCRYSTALLINE CELLULOSE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45591-041-96 177 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 12/14/2017
Labeler — Pierson Laboratories (119184992)
Registrant — Humco Holding Group, Inc. (825672884)
Establishment
Name Address ID/FEI Operations
Humco Holding Group, Inc. 825672884 label (45591-041), manufacture (45591-041), analysis (45591-041), pack (45591-041)

Revised: 12/2017 Pierson Laboratories

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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