Label: CORTISONE PLUS ALOE MAXIMUM STRENGTH- hydrocortisone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-319-16, 59779-319-56 - Packager: CVS Pharmacy
- 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 November 20, 2019
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- Drug Facts
- Active ingredient
- 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
•jewelry •detergents •cosmetics •psoriasis •seborrheic dermatitis• 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
Do not use
- for external feminine itching if you have a vaginal discharge. Consult a doctor.
- for the treatment of diaper rash. Consult a doctor.
When using this product
- avoid contact with the eyes • do not begin the use of any other hydrocortisone product unless directed by a doctor
- for external anal itching:
• do not use more than directed unless directed by a doctor
• do not put this product into the rectum by using fingers or any mechanical device or applicator
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Directions
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, clean the affected area with mild soap and warm water, 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
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Inactive ingredients
aloe vera concentrate, cetyl alcohol, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax. May contain citric acid or sodium citrate solution to adjust pH.
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INGREDIENTS AND APPEARANCE
CORTISONE PLUS ALOE MAXIMUM STRENGTH
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-319 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) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) METHYLPARABEN (UNII: A2I8C7HI9T) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) POLYSORBATE 60 (UNII: CAL22UVI4M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SORBIC ACID (UNII: X045WJ989B) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) WHITE WAX (UNII: 7G1J5DA97F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-319-56 1 in 1 CARTON 02/22/2012 04/30/2018 1 28 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:59779-319-16 1 in 1 CARTON 02/22/2012 2 56 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 02/22/2012 Labeler - CVS Pharmacy (062312574)
