BOA VIDA CALVIDA- zinc oxide cream

BOA VIDA Calvida by

Drug Labeling and Warnings

BOA VIDA Calvida by is a Otc medication manufactured, distributed, or labeled by Central Solutions Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Zinc Oxide 20% (w/w)

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

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.

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)

PRINCIPAL DISPLAY PANEL

BOA

VIDA

Calvida

protectant shield

helps treat minor

skin irritation

Formulated

with

Cupuacu Butter

5 fl oz. (148 mL)

INGREDIENTS AND APPEARANCE

BOA VIDA CALVIDA 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62654-145
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MINERAL OIL (UNII: T5L8T28FGP)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
THEOBROMA GRANDIFLORUM SEED (UNII: Q7RNT1G37V)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
MENTHOL (UNII: L7T10EIP3A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
YELLOW WAX (UNII: 2ZA36H0S2V)
TOCOPHEROL (UNII: R0ZB2556P8)
METHYLPARABEN (UNII: A2I8C7HI9T)
CORN OIL (UNII: 8470G57WFM)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CHOLECALCIFEROL (UNII: 1C6V77QF41)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62654-145-05	148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2011
2	NDC: 62654-145-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	11/01/2011

Labeler - Central Solutions Inc (007118524)

Establishment
Name	Address	ID/FEI	Business Operations
Central Solutions Inc		007118524	manufacture(62654-145)