Label: ANTI-ITCH- hydrocortisone cream
- NDC Code(s): 53329-091-01, 53329-091-90, 53329-091-91, 53329-091-96
- Packager: Medline Industries, LP
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 August 8, 2023
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- Official Label (Printer Friendly)
- Active ingredient (in each gram)
- Purpose
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Uses
- for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, scrapes
- for external genital, feminine and anal itching
- other uses of this product should be only under the advice and supervision of a doctor
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Warnings
- for external use only
- avoid contact with eyes
Do not use and consult a doctor
- for the treatment of diaper rash
- if you have a vaginal discharge
- If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.
Do not exceed the recommended daily dosage unless directed by the doctor. In case of bleeding, consult a physician promptly. Do not put this product into the rectum by using fingers or any mechanical device or applicator.
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Directions
- For 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.
For external anal itching,
- Adults: When practical, cleanse the affected area with mild soap and water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
- Children under 12 years of age: consult a doctor.
- Other information
- Inactive ingredients
- Manufacturing Information
- Package Label
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INGREDIENTS AND APPEARANCE
ANTI-ITCH
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-091 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 g Inactive Ingredients Ingredient Name Strength METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W) STEARIC ACID (UNII: 4ELV7Z65AP) WHITE PETROLATUM (UNII: B6E5W8RQJ4) WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TROLAMINE (UNII: 9O3K93S3TK) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-091-01 1 in 1 BOX 03/01/2010 1 28.4 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:53329-091-91 48 in 1 CARTON 03/01/2010 2 NDC:53329-091-90 1.5 g in 1 PACKET; Type 0: Not a Combination Product 3 NDC:53329-091-96 144 in 1 CASE 03/01/2010 3 28.4 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:53329-091-90 1.5 g in 1 PACKET; Type 0: Not a Combination Product 03/01/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/01/2010 Labeler - Medline Industries, LP (025460908) Registrant - Medline Industries, LP (025460908)
