Label: END-ITCH- oatmeal cream
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Contains inactivated NDC Code(s)
NDC Code(s): 60858-314-01, 60858-314-04 - Packager: Crystal Connections, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 January 3, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- WARNINGS
- PURPOSE
- DOSAGE & ADMINISTRATION
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- OTC - KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
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oatmeal creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60858-314 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 0.0287 g in 1 g Inactive Ingredients Ingredient Name Strength ALMOND OIL (UNII: 66YXD4DKO9) Yellow Wax (UNII: 2ZA36H0S2V) JOJOBA OIL (UNII: 724GKU717M) LANOLIN (UNII: 7EV65EAW6H) SODIUM CHLORIDE (UNII: 451W47IQ8X) LAVENDER OIL (UNII: ZBP1YXW0H8) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60858-314-04 113.4 g in 1 BOTTLE 2 NDC:60858-314-01 28.35 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 01/06/2014 Labeler - Crystal Connections, LLC (016582119) Establishment Name Address ID/FEI Business Operations American Pharmaceuticals and Cosmetics 038023805 manufacture(60858-314)
