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Best Choice Medicated Calamine

Dosage form: lotion
Ingredients: ZINC OXIDE 80mg in 1mL, PRAMOXINE HYDROCHLORIDE 10mg in 1mL
Labeler: Valu Merchandisers, CO.
NDC Code: 63941-420

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.

Best Choice Medicated Calamine Lotion

Drug Facts

Active Ingredients

Zinc Acetate 8%

Pramoxine HCl 1%

Purpose

Skin Protectant

External analgesic

Uses

Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, oak, and sumac or other skin irritations.

Warnings

For external use only. Use only as directed.

When using this product. Avoid contact with eyes and moucous membranes.

Ask a doctor before using on children 2 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 whitin a few days.

Keep out of reach of children.

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

Directions

Adults and children 2 yr. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort.

Children under 2 yrs. of age. Consult a doctor before use.

Inactive Ingredients

SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methycelulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben and Purified Water.

Other information

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

Label

BEST CHOICE MEDICATED CALAMINE 
zinc acetate and pramoxine hydrochloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-420
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC CATION) ZINC CATION80 mg  in 1 mL
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
CAMPHOR (NATURAL) 
DIAZOLIDINYL UREA 
GLYCERIN 
METHYLPARABEN 
POLYSORBATE 80 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
Packaging
#Item CodePackage Description
1NDC:63941-420-96177 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/25/1998
Labeler - Valu Merchandisers, CO. (868703513)
Registrant - Humco Holding Group, Inc. (825672884)
Establishment
NameAddressID/FEIOperations
Humco Holding Group, Inc825672884manufacture(63941-420), analysis(63941-420), pack(63941-420), label(63941-420)

 
Valu Merchandisers, CO.

Medically reviewed on Nov 7, 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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