LEADER CALDYPHEN- zinc oxide, pramoxine hydrochloride lotion

LEADER Caldyphen by

Drug Labeling and Warnings

LEADER Caldyphen by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Humco Holding Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

LEADER CALDYPHEN 
zinc oxide, pramoxine hydrochloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	8 mg  in 100 mL
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-130-30	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/15/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/15/2012

Labeler - Cardinal Health (097537435)

Registrant - Humco Holding Group, Inc. (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc.		825672884	manufacture(37205-130) , analysis(37205-130) , pack(37205-130) , label(37205-130)