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Calamine by Pierson Laboratories

Dosage form: lotion
Ingredients: ZINC OXIDE 160mg in 1mL
Labeler: Pierson Laboratories
NDC Code: 45591-041

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.

Calamine Lotion

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

CALAMINE 
calamine 8% and zinc oxide 8% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45591-041
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 
CARRAGEENAN 
XANTHAN GUM 
CALCIUM HYDROXIDE 
GLYCERIN 
WATER 
MICROCRYSTALLINE CELLULOSE 
Packaging
#Item CodePackage Description
1NDC:45591-041-96177 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/14/2017
Labeler - Pierson Laboratories (119184992)
Registrant - Humco Holding Group, Inc. (825672884)
Establishment
NameAddressID/FEIOperations
Humco Holding Group, Inc.825672884label(45591-041), manufacture(45591-041), analysis(45591-041), pack(45591-041)

 
Pierson Laboratories

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Medically reviewed on Dec 14, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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