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Sunmark Calamine

Medically reviewed on December 12, 2017.

Dosage form: lotion
Ingredients: ZINC OXIDE 160mg in 1mL
Labeler: McKesson
NDC Code: 49348-011

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.

Sunmark Calamine

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.

Package Principal Display Panel

Label

SUNMARK CALAMINE 
calamine 8% and zinc oxide 8% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-011
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC CATION) ZINC CATION160 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CALCIUM HYDROXIDE 
GLYCERIN 
WATER 
Packaging
#Item CodePackage Description
1NDC:49348-011-34177 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/2008
Labeler - McKesson (177667227)
Registrant - Humco Holding Group, Inc. (825672884)
Establishment
NameAddressID/FEIOperations
Humco Holding Group, Inc.825672884label(49348-011), manufacture(49348-011), pack(49348-011), analysis(49348-011)

 
McKesson

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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