Label: BAZA PROTECT- zinc oxide and dimethicone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 11701-046-14, 11701-046-22, 11701-046-23 - Packager: Coloplast Manufacturing US, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 15, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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SPL UNCLASSIFIED SECTION
Drug Facts
When using this product
- avoid contact with eyes
- not to be applied over deep or puncture wounds or lacerations.
Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control
Center right away.
Directions
- change wet and soiled diapers promptly
- apply to affected area and gently wipe with clean, soft cloth
- apply as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged.
Inactive ingredients
BHT, cetyl alcohol, cod liver oil, EDTA, fragrance, glyceryl stearate, lanolin oil, PEG-8 stearate, PEG-40 stearate, petrolatum, propylene glycol, quaternium-15, tocopheryl acetate, tricontanyl PVP, water
See crimp for lot no. and expiration date
Manufactured by: Coloplast A/S DK-3050 Humlebaek, Denmark
Distributed by: Coloplast Corp. Minneapolis, MN 55411 U.S.A.
1-800-533-0464 www.us.cobplast.com
Product #1880 ©2008-7, Coloplast Corp.
Made in the U.S.A.G8-773
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BAZA PROTECT
zinc oxide and dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11701-046 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 120 mg in 1 g DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) TRICONTANYL POVIDONE (UNII: N0SS3Q238D) PETROLATUM (UNII: 4T6H12BN9U) LANOLIN (UNII: 7EV65EAW6H) PEG-8 STEARATE (UNII: 2P9L47VI5E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PEG-40 STEARATE (UNII: ECU18C66Q7) EDETIC ACID (UNII: 9G34HU7RV0) COD LIVER OIL (UNII: BBL281NWFG) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) QUATERNIUM-15 (UNII: E40U03LEM0) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11701-046-22 4 g in 1 PACKET; Type 0: Not a Combination Product 06/15/2009 2 NDC:11701-046-23 57 g in 1 TUBE; Type 0: Not a Combination Product 06/15/2009 3 NDC:11701-046-14 142 g in 1 TUBE; Type 0: Not a Combination Product 06/15/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 06/15/2009 Labeler - Coloplast Manufacturing US, LLC (110326675) Registrant - Coloplast Corp (847436391) Establishment Name Address ID/FEI Business Operations Coloplast Manufacturing US, LLC 110326675 MANUFACTURE(11701-046)
