MAXIMUM STRENGTH HYDROCORTISONE - hydrocortisone ointment 
DLC Laboratories, Inc

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.

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Maximum Strength Hydrocortisone 1%

Active Ingredient

Hydrocortisone, USP 1%

Purpose

Antipuritic (Anti-Itch)

Uses

Warnings


For external use only.

Do not use

  • for the treatment of diaper rash. Consult a doctor
  • for external feminine itching if you have a vaginal discharge. Consult a doctor.

When using this product

  • avoid contact with the eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put this product into rectum by using fingers or any medical device or applicator

Stop use and ask a doctor

if

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

Keep out of the reach of children.

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

Directions

Adults and children 2 years of age and older:apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: do not use. Consult a doctor

Other information

store at room temperature 15-30C (59-86F)

Inactive Ingredients

mineral oil, petrolatum

Product Labeling

For fast relief of itching due to:

Maximum Strength  Hydrocortisone 1%
For relief of itching, rashes, and skin irritations


Hydrocortisone

Hydrocortisone

MAXIMUM STRENGTH HYDROCORTISONE 
hydrocortisone ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:24286-1560
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL 
PETROLATUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24286-1560-11 in 1 BOX
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/22/2013
Labeler - DLC Laboratories, Inc (093351930)

Revised: 3/2013
Document Id: b1f5b320-98db-4c06-89a6-b0767da14385
Set id: caf50f12-f35c-4e9e-8ef7-3b0c84e225ee
Version: 1
Effective Time: 20130322
 
DLC Laboratories, Inc