Label: HYDROCORTISONE- hydrocortisone 1% cream
- NDC Code(s): 68016-149-01
- Packager: Pharmacy Value Alliance LLC
- 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 May 9, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Keep out of Reach of Children
-
Uses
For temporary relief of itching associated with minor skin irritataions, inflammation and rashes due to
- Eczema
- Insect bites
- poison ivy
- poison oak
- poison sumac
- soaps
- detergents
- cosmetics
- jewelry
- seborrheic dermatitis
- psoriasis
- external feminine, genital and anal itching
Other uses of this product should be only under the advice and supervision of a doctor
- Warnings
-
When using this Product
- Avoid contact with the eyes.
- Do not begin the use of any other hydrocortisone product unless you have consulted a doctor.
- For external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use, consult a doctor
- Do not put this product into the rectum by using fingers or any mechanical device or applicator.
- Stop Using this product and ask a doctor if
-
Directions
Adults and children 2 years and older
- Apply to affected area not mroe than 3 to 4 times daily.
Children under 2 years of age
- Do not use
- Consult a doctor
For External and Anal Itching
- Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.
- Children under 12 years of age with external anal itching; consult a doctor.
- Other Information
- Inactive Ingredients
- Questions
- Other Information
- Packaging
-
INGREDIENTS AND APPEARANCE
HYDROCORTISONE
hydrocortisone 1% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-149 Route of Administration TOPICAL 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 POLYSORBATE 60 (UNII: CAL22UVI4M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) WATER (UNII: 059QF0KO0R) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE DISODIUM (UNII: 7FLD91C86K) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-149-01 1 in 1 BOX 01/09/2020 1 28 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/09/2020 Labeler - Pharmacy Value Alliance LLC (101668460) Registrant - Trifecta Pharmaceuticals USA LLC (079424163)
