Label: END-ITCH FOR SUNBURN cream
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Contains inactivated NDC Code(s)
NDC Code(s): 60858-316-03 - 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 May 7, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- WARNINGS
- OTC - PURPOSE SECTION
- OTC - ACTIVE INGREDIENT SECTION
- INACTIVE INGREDIENT SECTION
- INDICATIONS & USAGE SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION SECTION
- OTC - STOP USE SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
END-ITCH FOR SUNBURN
end-itch for sunburn creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60858-316 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength oatmeal (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) oatmeal 11.62 g in 1 g Inactive Ingredients Ingredient Name Strength ALMOND OIL (UNII: 66YXD4DKO9) YELLOW WAX (UNII: 2ZA36H0S2V) GRAPEFRUIT (UNII: O82C39RR8C) JOJOBA OIL (UNII: 724GKU717M) LANOLIN (UNII: 7EV65EAW6H) PEPPERMINT (UNII: V95R5KMY2B) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60858-316-03 90.71 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 05/15/2015 Labeler - Crystal Connections, LLC (016582119) Establishment Name Address ID/FEI Business Operations American Pharmaceutical and Cosmetics, Inc. 038023805 manufacture(60858-316)
