BOA VIDA CALVIDA - zinc oxide cream 
Central Solutions Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredients

Zinc Oxide 20% (w/w)

Purpose

Skin protectant

Uses

Helps treat and prevent diaper rash

Protects minor skin irritation due to diaper rash and helps seal out wetness

Warnings

For External Use Only

Do not use

on deep or puncture wounds

on animal bites

on serious burns

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 within a few days

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

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.

Other Information

Protect from freezing.

Avoid excessive heat

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)

BOA

VIDA

Calvida

protectant shield

helps treat minor

skin irritation

Formulated

with

Cupuacu Butter

5 fl oz. (148 mL)

container label

BOA VIDA CALVIDA 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62654-145
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE20 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
POLYGLYCERYL-4 ISOSTEARATE 
HEXYL LAURATE 
MINERAL OIL  
ISOPROPYL PALMITATE 
ETHYLHEXYL PALMITATE 
THEOBROMA GRANDIFLORUM SEED 
GLYCERIN 
DIMETHICONE 
SODIUM CHLORIDE 
DIAZOLIDINYL UREA 
MENTHOL 
HYDROGENATED CASTOR OIL 
YELLOW WAX 
TOCOPHEROL 
METHYLPARABEN 
CORN OIL 
VITAMIN A PALMITATE 
CHOLECALCIFEROL 
Packaging
#Item CodePackage Description
1NDC:62654-145-05148 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/01/2011
Labeler - Central Solutions Inc (007118524)
Establishment
NameAddressID/FEIBusiness Operations
Central Solutions Inc007118524manufacture

Revised: 11/2011
Document Id: 3a3b7881-7d82-43cb-a761-4e10320a7b27
Set id: 48eb2031-bc80-45d5-b8b3-cc08fcab64f1
Version: 1
Effective Time: 20111103
 
Central Solutions Inc