LEADER Caldyphen Clear: Package Insert and Label Information

LEADER CALDYPHEN CLEAR- pramoxine hydrochloride and zinc acetate lotion
Cardinal Health

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.

Drug Facts

Active Ingredients

Pramoxine HCl 1%

Zinc Acetate 0.1%

Purpose

  • External Analgesic
  • Skin Protectant

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, Hydrozyproyl 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 Clear Lotion 6oz/177ml (37205-281-30)

CaldyphenClear
(click image for full-size original)

LEADER CALDYPHEN CLEAR
pramoxine hydrochloride, zinc acetate lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-281
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 1 mg in 100 mL
ZINC ACETATE (ZINC CATION) ZINC CATION 0.1 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
CAMPHOR (NATURAL)
DIAZOLIDINYL UREA
GLYCERIN
HYPROMELLOSE 2208 (4000 MPA.S)
METHYLPARABEN
POLYSORBATE 80
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37205-281-30 177 mL in 1 BOTTLE None
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 Operations
Humco Holding Group, Inc. 825672884 manufacture (37205-281)

Revised: 01/2020 Cardinal Health

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