Grahams Natural Diaper Rash
FDA Label NDC 42387-135

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Grahams Natural Alternatives Pty Ltd for the product Grahams Natural Diaper Rash (NDC 42387-135). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, dosage & administration, warnings, otc - questions, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

ACTIVE INGREDIENT

Zinc Oxide 12%

Otc - Purpose

PURPOSE

Skin Protectant

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Indications & Usage

Uses and Indications

For the relief of diaper rash, minor cuts and burns

Dosage & Administration

Directions

Apply cream, liberally, and as often as necessary to dry skin, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Warnings

Warnings 

For external use only

Avoider contact with eyes. If any adverse reaction develops, stop use, and contact a physician.

Otc - Questions



Questions 

www.itchy.net.au

Made in Australia

Grahams Natural Alternatives Pty Ltd

7 Palings Crt, Nerang, QLD 4211 Australia

Inactive Ingredient

Inactive Ingredients

Purified Water, Betaine,
Glycerin, Cetearyl Alcohol, Glyceryl Stearate SE, Coco-
Caprylate, Prunus Amygdalus Dulcis (Sweet Almond) Oil),
Helianthus Annuus (Sunflower) Seed Oil, Butyrospermum
Parkii (Shea Butter), Beeswax, Caprylic/Capric
Triglyceride, Sodium Stearoyl Glutamate, Jojoba Oil,
Xanthan Gum, Chamomile Extract, Calendula Extract,
Tocopherol Acetate, Phenoxyethanol, Capryl Glycol

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