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DDM Calamine

Medically reviewed on November 6, 2017

Dosage form: lotion
Ingredients: ZINC OXIDE 160mg in 1mL
Labeler: Discount Drug Mart
NDC Code: 53943-413

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.

DDM Calamine Lotion

Drug Facts

active Ingredients

Calamine 8%

Zinc Oxide 8%

Purpose

Skin Protectant

Skin Protectant

Uses

Dries the oozing and weeping of poison ivy, poison oak, and poison sumac and other skin irritations.

Warnings

For external use only. Use only as directed.

Avoid contat with eyes and moucous membranes.

Ask a doctor

before using on children under 6 years of age.

Stop use and ask a doctor if

  • Condition worsens
  • Symptoms last for more than 7  days or clear up and occur again within a few days.

Keep out of reach of children.

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

Directions

Adults and children 6 mo. of age and older: Shake well before using. Cleanse the skin with soap and water. Let dry before each use. Apply lotion to the affected area using cotton or soft cloth, as often as needed for comfort.

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

Other information

Store at room temperature 15-30C (59-86F)

Inactive Ingredients

Bentonite Magma, Calcium Hydroxide, Glycerin, and Purified Water.

Questions or Comments?

Label

DDM CALAMINE 
calamine 8% and zinc oxide 8% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-413
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
BENTONITE 
CALCIUM HYDRIDE 
GLYCERIN 
WATER 
Packaging
#Item CodePackage Description
1NDC:53943-413-96177 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/2008
Labeler - Discount Drug Mart (047741335)
Registrant - Humco Holding Group, Inc. (825672884)
Establishment
NameAddressID/FEIOperations
Humco Holding Group, Inc.825672884manufacture(53943-413), analysis(53943-413), pack(53943-413), label(53943-413)

 
Discount Drug Mart

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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