LEADER Caldyphen

Dosage form: lotion
Ingredients: ZINC OXIDE 8mL in 100mL, PRAMOXINE HYDROCHLORIDE 1mL in 100mL
Labeler: Cardinal Health
NDC Code: 37205-130

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.

LEADER Caldyphen Lotion

Drug Facts


Active Ingredients


Calmine 8%

Pramoxine HCl 1%


Purpose
  • Skin Protectant
  • External Analgesic

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

Warnings: For external use only. Use only as directed.
  • Avoid contact with mucous membranes.

When using this product:
  • Discontinue use if condition worsens, does not improve or if symptoms persist for more than 7 days, or clear up and occur again within a few 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: (SHAKE WELL BEFORE USING)
  • Adults and children 2 yrs. of age and older:Apply lotion to the affected area not more than 2 to 4 times daily.
  • Children under 2 yrs. of age: Consult  a doctor.

Other Information:

Store at temperature 15 degrees - 25 degrees C ( 59 degrees - 77 degrees F)

Inactive Ingredients:

SD Alcohol 38B 2.5% , Camphor, Diazoldinyl Urea, Fragrances, Glycerin, Hydroxyproyl Methylcellulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben and Purified Water.

Distributed by: Cardinal Health Dublin, Ohio 43017 1-800-200-6313 www.myleader.com

All Leader Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

LEADER Caldyphen Lotion 6oz/177ml (37205-130-30)

LEADER CALDYPHEN 
zinc oxide, pramoxine hydrochloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-130
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE8 mL  in 100 mL
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
CAMPHOR (NATURAL) 
DIAZOLIDINYL UREA 
GLYCERIN 
HYPROMELLOSE 2208 (4000 MPA.S) 
METHYLPARABEN 
POLYSORBATE 80 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
Packaging
#Item CodePackage Description
1NDC:37205-130-30177 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34803/15/2012
Labeler - Cardinal Health (097537435)
Registrant - Humco Holding Group, Inc. (825672884)
Establishment
NameAddressID/FEIOperations
Humco Holding Group, Inc.825672884manufacture

Revised: 03/2012
 
Cardinal Health

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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