Otc - Active Ingredient
Active ingredients:
Zinc Oxide 15% Purpose Skin protectant
Diaper Rash Cream
FDA Label NDC 83369-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Smalls Brand Llc Dba Roe Wellness for the product Diaper Rash Cream (NDC 83369-002). 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, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses: Helps prevent irritation
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Stop use and ask a doctor if rash occurs
Warnings
Warning:
- For external use only. When using this product keep out of eyes. Rinse with water to remove
Dosage & Administration
Directions: After changing diaper allow the area to dry. then apply diaper rash cream liberally to affected areas.
Inactive Ingredient
Water, Caprylic/Capric Triglyceride, Glycerin. C13-15 Alkane, Ethylhexyl Olivate, Propanediol, Polyglyceryl-3 Polyricinoleate, Bis-Octyldodecylhexyl Dimer Dilinoleate/Propanediol Copolymer, Cocoglycerides, Meadowfoam Estolide, Disteardimonium Hectorite, Jojoba Esters, Hydrogenated Castor Oil, Lactococcus Ferment Lysate, Rhus Verniciflua Peel Wax, Squalane, 1,2-Hexanediol, Butyrospermum Parkii (Shea) Butter, Caprylyl Glycol, Pyrus Malus (Apple) Fruit Extract, Sodium Chloride, Linoleic Acid, Betaine, Sucrose, Hydroxyacetophenone, Phospholipids, Phytosterols, Sodium Citrate, Hydrolyzed Rhodophyceae Extract, Bisabolol, Panthenol, Sodium Dehydroacetate, Stearyl Glycyrrhetinate, Tocopherol, Tetrasodium Glutamate Diacetate, Linolenic Acid, Avena Sativa (Oat) Kernel Extract.
Package Label.Principal Display Panel
Diaper Rash Cream
alleviate + soothe
Net Wt oz 85g
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