Label: DERMOSCRIBE DIAPER- clioquinol, zinc oxide ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 69683-102-11 - Packager: DERMOSCRIBE PTY LTD
- 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 December 22, 2022
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- ACTIVE INGREDIENTS:
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DIRECTIONS:
WASH HANDS WITH SOAP AND WATER BEFORE AND AFTER USE. USING FINGERS, GENTLY APPLY OINTMENT OVER AFFECTED AREA. FOLLOWING AN INITIAL FLARE-UP, APPLY OINTMENT AFTER EVERY DIAPER CHANGE. ONCE THE RASH HAS SETTLED, APPLY TWO OR THREE TIMES DAILY, AS REQUIRED. ASK YOUR HEALTHCARE PROFESSIONAL IF YOU ARE UNSURE OF THE CORRECT DOSAGE FOR YOUR BABY.
- INACTIVE INGREDIENTS
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DERMOSCRIBE DIAPER
clioquinol, zinc oxide ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69683-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLIOQUINOL (UNII: 7BHQ856EJ5) (CLIOQUINOL - UNII:7BHQ856EJ5) CLIOQUINOL 1 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 15 g in 100 g Inactive Ingredients Ingredient Name Strength OLIVE OIL (UNII: 6UYK2W1W1E) BORIC ACID (UNII: R57ZHV85D4) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) YELLOW WAX (UNII: 2ZA36H0S2V) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PARAFFIN (UNII: I9O0E3H2ZE) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LANOLIN (UNII: 7EV65EAW6H) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69683-102-11 100 g in 1 JAR; Type 0: Not a Combination Product 03/23/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/23/2015 Labeler - DERMOSCRIBE PTY LTD (742164734)