Label: HYDROCORTISONE- hydrocortisone liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-318-03 - Packager: CVS Pharmacy
- 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 July 16, 2010
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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PURPOSE
Active ingredient Purpose
Hydrocortisone 1%...................................External analgesic
Uses Temporarily relieves itching associated with minor skin
irritation and rashes due to saborrheic dermatitis and psoriasis.
Other uses of this product should be only used under the advice
and supervision of a doctor.
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only.
When using this product
- do not get into eyes. If contact occurs, rinse eyes thoroughly with water. If irritation persists, consult a doctor.
Stop use of this product and do not begin use of any other hydrocortisone product if
- condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, unless you have consulted a doctor.
Keep out of reach of children. If swallowed, get medical
help or contact a Poison Control Center right away.
Flammable, Keep away from fire or flame.
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HYDROCORTISONE
hydrocortisone liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-318 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) MENTHOL (UNII: L7T10EIP3A) TEA TREE OIL (UNII: VIF565UC2G) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) EDETATE DISODIUM (UNII: 7FLD91C86K) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-318-03 1 in 1 CARTON 1 44 mL in 1 BOTTLE, DISPENSING Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part348 07/16/2010 Labeler - CVS Pharmacy (062312574) Registrant - Pharma Pac, LLC (140807475) Establishment Name Address ID/FEI Business Operations Pharma Pac, LLC 140807475 manufacture