Label: RUGBY HYDROSKIN- hydrocortisone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 0536-1069-95 - Packager: Rugby Laboratories
- 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 December 5, 2017
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- ACTIVE INGREDIENT
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PURPOSE
Uses for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:
- eczema
- seborrheic dermatitis
- psoriasis
- insect bites
- poison ivy, oak, sumac
- soaps
- detergents
- cosmetics
- jewelry
- 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
Warnings
- for external use only
Do not use in the genital area if you have a vaginal discharge. Consult a doctor.
Do not use for the treatment of diaper rash. 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 directly into the rectum by using fingers or any mechanical device or applicator - STOP USE
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Directions
For itching of skin iritation, inflammation, and rashes:
- 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 and genital itching, adults:
- when practical, clean the affected area with mild soap and warm water and rinse thoroughly.
- gently dry by patting or blotting with toilet tissue or soft cloth before applying
- apply to affected area not more than 3 to 4 times daily
- children under 12 years of age: consult a doctor
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RUGBY HYDROSKIN
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1069 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MINERAL OIL (UNII: T5L8T28FGP) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1069-95 1 in 1 CARTON 07/15/2015 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 07/15/2015 Labeler - Rugby Laboratories (079246066)