Label: LOESCH HC-10 ANTI-ITCH THERAPY- hydrocortisone liquid liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 25280-008-02 - Packager: Loesch Laboratory Consultants, INC.
- 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 November 1, 2017
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
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Use
•Specially formulated to rapidly and completely penetrate the skin delivering itch relief anywhere it's needed. •This liquid preparation can be applied to the skin or scalp to temporarily relieve minor itching and skin irritations commonly associated with insect bites, poison ivy, poison oak, poison sumac, and skin blemishes.
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Warnings
•Not for use on children under 2 years old except as directed by a pediatrician. •Avoid contact with eyes and mucous membranes. •Do not apply to large areas of the body and do not use for extended periods of time. •For external use only. •If irritation develops and persists, discontinue use and ask a doctor. •When using this product, if condition worsens or if symptoms persists for more than 7 days or clear up and occur again within a few days, stop use and ask a doctor.
- Keep out of reach of children
- Directions
- Other information
- Inactive Ingredients
- Questions or Comments
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LOESCH HC-10 ANTI-ITCH THERAPY
hydrocortisone liquid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:25280-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 9 mg in 1 mL Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) Isopropyl Alcohol (UNII: ND2M416302) Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Laureth-4 (UNII: 6HQ855798J) Tert-Butyl Alcohol (UNII: MD83SFE959) Brucine Sulfate (UNII: KY7O12XPOQ) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:25280-008-02 59.2 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2015 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/01/2015 Labeler - Loesch Laboratory Consultants, INC. (026619510) Establishment Name Address ID/FEI Business Operations Bio-Medical & Pharmaceutical Manufacturing Corporation 072186356 manufacture(25280-008)
