OTC Medication Information: Caldyphen Clear

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.

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

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg in 1 mL
ZINC ACETATE (ZINC CATION) ZINC CATION 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CAMPHOR (NATURAL)
DIAZOLIDINYL UREA
GLYCERIN
HYPROMELLOSE, UNSPECIFIED
METHYLPARABEN
POLYSORBATE 80
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24385-439-30 177 mL in 1 BOTTLE, PLASTIC None
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)

Revised: 06/2020 Amerisource Bergen

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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