Label: HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE- hydrocortisone cream
- NDC Code(s): 63187-567-01
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 0904-7623
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated February 1, 2024
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- Official Label (Printer Friendly)
- 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
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- insect bites
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- poison ivy
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- poison oak
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- poison sumac
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- soaps
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- jewelry
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- detergents
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- cosmetics
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- psoriasis
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- seborrheic dermatitis
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- for external genital, feminine and anal itching
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- other uses of this product should be only under the advice and supervision of a doctor
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
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Directions
Adults and children 2 years of age and older
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- 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.
- Questions?
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PRINCIPAL DISPLAY PANEL
Maximum Strength
Relabeled by:
Proficient Rx LP
Thousand Oaks, CA 91320
NDC 63187-567-01
Hydrocortisone ● 10
Hydrocortisone Cream, USP 1%
antipruritic (anti-itch) cream with Aloe
NET WT 1 OZ (28 g)
Compare to the Active ingredient in Cortizone • 10®*
Temporary Relief of Itching and Rashes Due to:· Insect Bites
· Eczema
· Soaps
· Poison Ivy, Oak, Sumac
· Seborrheic Dermatitis
· Cosmetics
· Psoriasis
· Jewelry
· Detergents03390311B1 VC110479 Rev 06/11
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INGREDIENTS AND APPEARANCE
HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-567(NDC:0904-7623) 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) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) METHYLPARABEN (UNII: A2I8C7HI9T) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) WHITE WAX (UNII: 7G1J5DA97F) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) POLYSORBATE 60 (UNII: CAL22UVI4M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBIC ACID (UNII: X045WJ989B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63187-567-01 1 in 1 CARTON 12/01/2018 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 Drug M017 04/21/2009 01/31/2025 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 REPACK(63187-567) , RELABEL(63187-567)