Label: MAXIMUM STRENGTH HYDROCORTISONE - hydrocortisone ointment
- NDC Code(s): 24286-1560-1
- Packager: DLC Laboratories, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Active Ingredient
Hydrocortisone, USP 1%Close
- for the temporary relief of itching associated with minor itching associated with minor skin irritatitions, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis
- for external genital, feminine and anal itching
- other uses of this product should be only under the advice and supervision of a doctor
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
- 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.
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 doctorClose
- Other information
store at room temperature 15-30C (59-86F)Close
- Inactive Ingredients
mineral oil, petrolatumClose
- Product Labeling
For fast relief of itching due to:
- Eczema and Psoriasis
- Insect bites
- Soaps and detergents
- Poison Ivy and Poison Sumac
For relief of itching, rashes, and skin irritations
- INGREDIENTS AND APPEARANCE
MAXIMUM STRENGTH HYDROCORTISONE
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:24286-1560 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 1 g in 100 g Inactive Ingredients Ingredient Name Strength MINERAL OIL PETROLATUM 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)