Label: INSTANT COOLING ITCH RELIEF CVS- 1% hydrocortisone spray
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-233-03 - Packager: CVS
- Category: HUMAN OTC DRUG LABEL
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 19, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only.
Flammable:Keep away from fire or flame
Avoid contact with the eyes. If condition worsens, or if
symptoms persist for more than 7 days or clear up and occur
again within a few days, stop use of this product and do not
begin use of any other hydrocortisone product unless you have
consulted a doctor. Do not use for the treatment of diaper rash.
Consult a doctor.
Do not puncture or incinerate. Contents under pressure. Do not
store at temperatures above 120˚F
- Keep out of reach of children.
- Directions
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
INSTANT COOLING ITCH RELIEF CVS
1% hydrocortisone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-233 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) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-233-03 85 g in 1 CAN; Type 0: Not a Combination Product 11/11/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/11/2014 Labeler - CVS (062312574) Registrant - Product Quest Mfg, LLC (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg, LLC 927768135 manufacture(59779-233) , label(59779-233)