Other
Drug Facts
For external use only
Calming Diaper Rash
FDA Label NDC 52915-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Organic & Sustainable Beauty for the product Calming Diaper Rash (NDC 52915-100). 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 ingredient, purpose, uses, otc - when using, otc - stop use, otc - keep 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 Ingredient
Zinc Oxide 12%
Purpose
Skin Protectant
Uses
- helps treat and prevent diaper rash
- protects chafed skin due to diaper rash
- helps seal out wetness
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove
Otc - Stop Use
Stop use and ask a doctor if condition worsens. If symptoms last more than 7 days or clear up and occur again within a few 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
- apply an even layer for everyday protection and when a rash is present
Other Information
- protect the product in this container from excessive heat and direct sunlight
- report serious adverse reactions to: 5933 Bowcroft St. Los Angeles, CA 90016
Inactive Ingredients
Water, glyceryl stearate, cetearyl alcohol, glyceryl caprylate, lanolin, calendula officinalis flower extract, viola tricolor extract, cocos nucifera (coconut) oil, caprylic/capric triglyceride, glycerin, cetyl alcohol, levulinic acid, squalane, lavandula angustifolia (lavender) oil, salvia sclarea (clary) oil, melaleuca alternifolia (tea tree) leaf oil, carthamus tinctorius (safflower) oleosomes, p-anisic acid, allantoin, xanthan gum, oenothera biennis (evening primrose) oil, phytic acid, yucca schidigera root extract, aloe barbadensis leaf juice, stearyl glycyrrhetinate.
Principal Display Panel - 82 G Tube Label
CALIF♥RNIA BABY®
trusted since 1995
IMPROVED
calming™
DIAPER RASH
CREAM
SKIN PROTECTANT
FRENCH LAVENDER • ZINC OXIDE
HELPS TO PREVENT & RELIEVE
ULTRA-PURIFIED LANOLIN • CONCENTRATED
NO GLUTEN, SOY, OAT OR DAIRY
PURE ESSENTIAL OILS
CLOTH DIAPER SAFE
ALLERGY
TESTED
• for babies • kids •
• sensitive adults •
Net Wt. 82 g/2.9 Oz.
Principal Display Panel (82 g Tube Label)
* Please review the disclaimer below.
