Active Ingredients
Dimethicone 2.0%, Zinc Oxide 10.0%
Tender Moments Delicate Baby Diaper Rash Balm Cream
FDA Label NDC 68828-700
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Distribuidora Comercial Jafra, S.a. De C.v. for the product Tender Moments Delicate Baby Diaper Rash Balm (NDC 68828-700). 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, directions, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
When using this product do not get into eyes.
Stop use and ask a doctor if
▪ condition worsens
▪ symptoms last more than 7 days or clear up and occur again in a few days
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
▪ Change wet and soiled diapers promptly, cleanse 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 diapers may be prolonged
Inactive Ingredients
Water/Aqua, Petrolatum, Isopropyl Palmitate, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Ethylhexyl Stearate, Cetyl Dimethicone, Magnesium Sulfate, Beeswax/Cera Alba, Butyrospermum Parkii (Shea Butter), Panthenol, Butylene Glycol, Avena Sativa (Oat) Kernel Extract, DMDM Hydantoin, Glycine Soja (Soybean) Oil, Aloe Barbadensis Oil
Product Label
Image Description (Image 1)
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