Label: HYDROCORTISONE CREAM 1% cream
- NDC Code(s): 70512-101-30
- Packager: SOLA Pharmaceuticals
- 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.
Updated February 13, 2021
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- Active Ingredient
Relieves itches and rashes due to:
- Seborrheic dermatitis
- Poison ivy
- Poison oak
- Poison sumac
- Insect bites
- External anal itching
Temporary relief of external anal and genital itching.
Other use of the product should only be under the advice and supervision of a doctor.
For external use only
Do not use:
- In the eyes
- For diaper rash
- If you have vaginal discharge
- More than the recommended dosage
Ask doctor before use:
- If you are pregnant or breast feeding
Stop use and ask a doctor if:
- Condition worsens, or is symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor.
When using this product:
- Do not put this product into rectum by using fingers or any mechanical device or applicator.
- KEEP OUT OF REACH OF CHILDREN
- Adults and children over 2 years of age - Apply to affected area not more than 3-4 times per day.
Children under 2 years of age - Do not use. Consult a doctor.
- For external anal itching Adults - When practical cleanse the affcted area with mild soap and water and rinse thoroughly. Gently dry patting with bathroom tissue or soft cloth before applying. Apply to affected area not more than 3-4 times per day. Children under 12 years of age: consult a doctor.
- Other Information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
HYDROCORTISONE CREAM 1%
hydrocortisone cream 1% cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70512-101 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 WATER (UNII: 059QF0KO0R) PETROLATUM (UNII: 4T6H12BN9U) CETETH-20 (UNII: I835H2IHHX) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) CHLOROCRESOL (UNII: 36W53O7109) MINERAL OIL (UNII: T5L8T28FGP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM METABISULFITE (UNII: 4VON5FNS3C) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70512-101-30 1 in 1 CARTON 04/16/2020 1 30 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 04/16/2020 Labeler - SOLA Pharmaceuticals (080121345)