Caladrox
FDA Label NDC 54162-229

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geritrex Llc for the product Caladrox (NDC 54162-229). 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 drug facts, uses, directions, warnings, inactive ingredients, keep out of reach of children, storage, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient:            Purpose:

Menthol 0.44%                External analgesic

                                      First aid antiseptic / antipruritic

Zinc Oxide 20.0%            Skin protectant / moisture barrier

Uses

A moisture barrier that prevents and helps heal skin irritation from Urine, diarrhea, perspiration, fistula drainge, feeding tube site leakage, wound drainage (peri-wound skin), minor burns, cuts, scrapes, itching

Directions

Cleanse skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply a thin layer of Caladrox Ointment to reddened or irritated skin 2-4 times daily or after each incontinent episode or diaper change to promote comfort and long lasting protection

Warnings

FOR EXTERNAL USE ONLY

Not for deep or puncture wounds

Avoid contact with eyes

If condition worsens or does not improve within 7 days, consult a doctor

Inactive Ingredients

Calamine, DMDM Hydantoin, Glycerin, Lanolin, Methylparaben, Mineral Oil, Petrolatum, Phenol, Propylparaben, Propylene Glycol, Purified Water, Sodium Laureth Sulfate, Stearyl Alcohol, Sorbitan Sesquioleate, Sodium bicarbonate and Thymol

Keep Out Of Reach Of Children

In the event of accidental ingestion contact a Poison Control Center right away

Storage

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

Dosage & Administration

Apply a thin layer of Caladrox Ointment to reddened or irritated skin 2-4 times daily.

Package Label.Principal Display Panel

Label Of Tube (Cxt4)

Label Of Tube (Cxt4)

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