Other
Drug Facts
Manufactured by:
Fischer Pharmaceuticals Ltd.
Tel Aviv, POB 39071, Israel.
Pure Baby Diaper Rash
FDA Label NDC 59886-414
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fischer Pharmaceuticals Ltd for the product Pure Baby Diaper Rash (NDC 59886-414). 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 other, active ingredients, purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Zinc Oxide 12%
Purpose
Skin Protectant
Uses
- Helps treat and prevent diaper rash
- Protects chafed skin due to diaper rash and helps seal out wetness.
Warnings
For external use only.
Otc - When Using
When using this product avoid contact with the eyes.
Otc - Stop Use
Stop use and ask a doctor if condition worsens or lasts more than 7 days.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Change wet and solid diapers promptly
- Clean the diaper area and allow to dry
- Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged.
Inactive Ingredients
Bisabolol, Calendula Officinalis Flower Extract, Caprylic/Capric Triglyceride, Coco-Caprylate, Dunaliella Salina Extract, Ethylhexylglycerin, Globularia Alypum Leaf Extract, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Castor Oil, Magnesium Sulfate, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-3 Diisostearate, Potassium Sorbate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sodium Benzoate, Tocopherol, Water.
Questions Or Comments?
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Principal Display Panel - 113 G Tube Label
Dr. Fischer®
Pure
baby
Diaper Rash Cream
100%
ORGANIC OILS
Helps Treat &
Prevent
With
Natural
Origin Ingredients
SCIENCE INSIDE
- SCIENCE INSIDE -
Hypoallergenic • Sensitive Tested
NO
Fragrance, Parabens, SLS, SLES,
Lanolin, Silicones, Paraffin, GMOs
Net Wt. 4 oz. (113 g.)
FISCHER PHARMACEUTICALS
Principal Display Panel (113 g Tube Label)
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