Drug Facts 62654-144

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	2 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:62654-144-05	148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2011
2	NDC:62654-144-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	11/01/2011

Labeler - Central Solutions Inc (007118524)

Name	Address	ID/FEI	Business Operations
Establishment
Central Solutions Inc		007118524	manufacture(62654-144)