Derma Gran
FDA Label NDC 64772-126

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Derma Sciences Canada, Inc. for the product Derma Gran (NDC 64772-126). 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 ingredients:, purpose, uses:, warnings:, otc - stop use, do not use on, keep this and all medicines out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients:

→ Purpose

→ Uses:

→ Warnings:

→ Otc - Stop Use

→ Do Not Use On

→ Keep This And All Medicines Out Of Reach Of Children.

→ Directions

→ Other Ingredients:

→ Customer Storage:

→ Principal Display Panel

Active Ingredients:

Aluminium Hydroxide Gel 0.275%

Purpose

Skin Protectant

Uses:

Dries the oozing, and weeping of poison ivy, poison oak, or poison sumac.
For the temporary protection, comfort and lubrication of minor skin irritations such as intertrigo, chafing, galling, rubbing or friction.

Warnings:

For external use only.

Avoid contact with eyes.

Not to be applied over deep or puncture wounds, infections or lacerations. Consult a physician.

Otc - Stop Use

If condition worsens or does not improve within 7 days stop use and consult a physician.

Do Not Use On

children under 6 months of age without consulting a physician.

Keep This And All Medicines Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Cleanse area and dry thoroughly. Apply as needed, directly to the affected area.

Other Ingredients:

Calcium carbonate, Lanolin, Magnesium hydroxide, Methlyparaben, Petrolatum, Propylene glycol, Propylparaben, Sodium Chloride, Sodium Lauryl Sulfate, Stearyl alcohol, Vitamin A Palmitate, Water, Zinc Chloride.