Caldyphen Clear

Caldyphen Clear

Drug Labeling and Warnings

Drug Details

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CALDYPHEN CLEAR- pramoxine hydrochloride and zinc acetate lotion 
Amerisource Bergen

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.

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Caldyphen Clear

Drug Facts

Active Ingredient

Pramoxine HCl 1%

Purpose

External analgesic

Active Ingredient

Zinc Acetate 0.1%

Purpose

Skin protectant

Uses

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

Warnings 

For External Use Only. Use only as directed. Avoid contact with eye and mucous membranes. ask a doctor before using on children under 2 years of age.

Stop use and as a doctor if

condition worsens. Symptoms last for more than 7 days or celar up and occur again whitin a few days.

Keep out of reach of children

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

Directions

Adults and children 2 yrs. of age and older. Shake well before using. cleanse the skin with soap and water. Let dry before each use. apply lotion to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort.

children unedr 2 yrs. of age. Consult a doctor before use.

Inactive Ingredients

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

Other information

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

Distributed by: AmerisourceBergen

1300 Morris Drive, Chesterbrook, PA 19087

Questions or comments?

1-800-662-3435  www.goodneighborpharmacy.com

Principal Display Panel

Good Neighbor Pharmacy  NDC: 24385-439-30

Caldyphen Lotion Clear

External Analgesic/Skin Protectant

Relieves ITCHING due to:

Poison Ivy    Insect Bites

Poison Oak   Minor Skin Irritations

6FL OZS (177 mL)

image description

CALDYPHEN CLEAR 
pramoxine hydrochloride and zinc acetate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 24385-439
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYPROPYL METHYLCELLULOSE E5 [II] (UNII: R75537T0T4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 24385-439-30177 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2008
Labeler - Amerisource Bergen (007914906)

Revised: 6/2013
 
Amerisource Bergen


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