Label: COOLING ITCH RELIEF RITE AID- hydrocortisone 1% spray
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Contains inactivated NDC Code(s)
NDC Code(s): 11822-1223-3 - Packager: Rite Aid
- 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 June 12, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient Purpose
- PURPOSE
- Uses
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Warnings
For external use only
When using this product
• Keep out of eyes. Rinse with water to remove • Use only as directed. • Do not puncture or incinerate. Contents under pressure
• Do not store at temperature above 120F - Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COOLING ITCH RELIEF RITE AID
hydrocortisone 1% sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-1223 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydrocortisone (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) Hydrocortisone 1 g in 100 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM (UNII: 7FLD91C86K) Glycerin (UNII: PDC6A3C0OX) Poloxamer 188 (UNII: LQA7B6G8JG) Polysorbate 20 (UNII: 7T1F30V5YH) ALCOHOL (UNII: 3K9958V90M) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-1223-3 85 g in 1 CAN; Type 0: Not a Combination Product 02/07/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/07/2013 Labeler - Rite Aid (014578892) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(11822-1223) , label(11822-1223)