OTC Medication Information: CVS Health Maxium Strentgh Cortisone

CVS HEALTH MAXIUM STRENTGH CORTISONE- hydrocortisone lotion
CVS Pharmacy

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.

Active ingredient Purpose

Hydrocortisone 1%………………………………………….. Anti-itch

Uses

  • temporarily relieves external feminine itching
  • other uses of this product should only be used under the advice and supervision of a doctor

Warnings

For external use only

Do not use

  • for the treatment of diaper rash. Consult a doctor.
  • if you have vaginal discharge. Consult a doctor.
  • if you are allergic to any ingredient in this product.

When using this product

  • avoid contact with eyes
  • do not use more than directed unless told to do so by a doctor

Stop use and ask a doctor if

  • condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • shake well before use
  • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly then gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  • adults and children 12 years of age and older: apply a fingertip amount (approxametly 1-inch strip) to affected area not more than 3 to 4 times daily
  • children under 12 years: ask a doctor

Other information

  • store at room temperature
  • Lot No. & Exp. Date: see bottom of container

Inactive ingredients

benzyl alcohol, butylated hydroxytoluene, ceteth-20, cetyl alcohol, lactic acid, mineral oil, propylene glycol, purified water, sorbitan monostearate, stearyl alcohol

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

Made in Korea

54301.1
(click image for full-size original)

CVS HEALTH MAXIUM STRENTGH CORTISONE
hydrocortisone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-774
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL
BUTYLATED HYDROXYTOLUENE
CETETH-20
CETYL ALCOHOL
LACTIC ACID
MINERAL OIL
PROPYLENE GLYCOL
WATER
SORBITAN MONOSTEARATE
STEARYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-774-04 118 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 04/25/2016
Labeler — CVS Pharmacy (062312574)

Revised: 01/2018 CVS Pharmacy

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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