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.

----------

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 Type HUMAN OTC DRUG Item Code (Source) NDC:24286-1560
Route of Administration TOPICAL DEA Schedule     
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
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:24286-1560-1 1 in 1 BOX
1 28 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 03/22/2013
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