CALDYPHEN CLEAR- pramoxine hydrochloride and zinc acetate lotion

Caldyphen Clear by

Drug Labeling and Warnings

Caldyphen Clear by is a Otc medication manufactured, distributed, or labeled by Amerisource Bergen. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

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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)

INGREDIENTS AND APPEARANCE

CALDYPHEN CLEAR 
pramoxine hydrochloride and zinc acetate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24385-439
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 mL
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
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: 24385-439-30	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/28/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/01/2008

Labeler - Amerisource Bergen (007914906)