Otc - Active Ingredient
Active Ingredients
Zinc Oxide 20% (w/w)
Boa Vida Calvida Cream
FDA Label NDC 62654-145
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Central Solutions Inc for the product Boa Vida Calvida (NDC 62654-145). 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, indications & usage, warnings, otc - do not use, 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
Otc - Purpose
Purpose
Skin protectant
Indications & Usage
Uses
Helps treat and prevent diaper rash
Protects minor skin irritation due to diaper rash and helps seal out wetness
Warnings
Warnings
For External Use Only
Otc - Do Not Use
Do not use
on deep or puncture wounds
on animal bites
on serious burns
Otc - When Using
When using this product
do not get into eyes
Otc - Stop Use
Stop use and ask a doctor if
condition worsens
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.
Dosage & Administration
Directions
For Diaper Rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.
Apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
For Skin Protection: Apply liberally as needed.
Storage And Handling
Other Information
Protect from freezing.
Avoid excessive heat
Inactive Ingredient
Inactive Ingredients
Purified Water, Polyglyceryl-4 Isostearate and Cetyl PEG/PPG-10/1 Dimethicone and Hexyl Laurate, Mineral Oil, Isopropyl Palmitate, Ethylhexyl Palmitate, Theobroma Grandiflorum Seed (Cupuacu Butter), Calamine, Glycerin, Cetyl Dimethicone, Dimethicone, SD Alcohol 40-B, Sodium Chloride, Diazolidinyl Urea, Menthol, Hydrogenated Castor Oil, Beeswax, Tocopherol (Vitamin E), Methyl Paraben, Zea Mays Oil and Retinyl Palmitate (Vitamin A) and Cholecalciferol (Vitamin D3)
Package Label.Principal Display Panel
BOA
VIDA
Calvida
protectant shield
helps treat minor
skin irritation
Formulated
with
Cupuacu Butter
5 fl oz. (148 mL)
* Please review the disclaimer below.
