Label: HYDRO SKIN- hydrocortisone lotion
- NDC Code(s): 0536-5105-97
- Packager: Rugby Laboratories
- 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
- for temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
- poison ivy, oak, sumac
- insect bites
- seborrheic dermatitis
- external genital 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. Ask a doctor.
- for external genital itching if you have a vaginal discharge. Ask a doctor.
When using this product
- avoid contact with the eyes
- do not begin use of any other hydrocortisone product unless you have asked a doctor
- for external anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly.
- do not put this product into the rectum by using fingers or any mechanical device or applicator
Stop use and ask a doctor if
- condition worsens
- 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.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
shake well before use
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. Ask a doctor.
for external anal itching:
- adults: when practical, cleanse the affected area with mild soap and warm 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 with external anal itching: ask a doctor
- Inactive ingredients
benzyll alcohol, emulsifying wax, glycerin, isopropyl palmitate, lactic acid, purified water, sorbitol 70% solutionClose
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- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0536-5105 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 1 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER BENZYL ALCOHOL GLYCERIN ISOPROPYL PALMITATE LACTIC ACID SORBITOL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-5105-97 118 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 10/29/2012 Labeler - Rugby Laboratories (191427277)