Caldyphen Clear Lotion
FDA Label NDC 24385-439

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amerisource Bergen for the product Caldyphen Clear (NDC 24385-439). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, stop use and as a doctor if, keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

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, 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)

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)

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