BOA VIDA CANOPY  - dimethicone 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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Drug Facts

Active Ingredients

Dimethicone 2.0% (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

Temporarily protects and helps relieve chapped or cracked skin

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 for 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

Apply liberally as often as needed

Other Information

Protect from freezing.

Avoid excessive heat

Inactive Ingredients

Water, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate,Cyclotetrasiloxane, Cyclopentasiloxane, Mineral Oil, Isopropyl Palmitate, Ethylhexyl Palmitate, Theobroma Grandiflorum Seed (Cupuacu Butter), Glycerin, Cetyl Dimethicone, Tocopherol (Vitamin E), Beeswax, Diazolidinyl Urea, Hydrogenated Castor Oil, Retinyl Palmitate (Vitamin A), Cholecalciferol (Vitamin D3), Beeswax, Zea Mays Oil, Methyl Paraben, Fragrance, Sodium Chloride



BOA

VIDA

Canopy

skin protectant

helps prevent minor

skin irritation

Formulated

with

Cupuacu Butter

5 fl oz. (148 mL)

container label

BOA VIDA CANOPY  
dimethicone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62654-144
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 2 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
QUADROSILAN (UNII: C5KT601WPM)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
THEOBROMA GRANDIFLORUM SEED (UNII: Q7RNT1G37V)  
GLYCERIN (UNII: PDC6A3C0OX)  
TOCOPHEROL (UNII: R0ZB2556P8)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
CORN OIL (UNII: 8470G57WFM)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62654-144-05 148 mL in 1 BOTTLE, PLASTIC
2 NDC:62654-144-04 118 mL in 1 BOTTLE, PLASTIC
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(62654-144)

Revised: 9/2013
Document Id: f43a0dc2-3c0e-42ca-86dc-2d4f3907814a
Set id: 44c98a3f-02f1-46ae-9fb0-1eb822b5ceaf
Version: 2
Effective Time: 20130912
 
Central Solutions Inc