Label: HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone cream
- NDC Code(s): 61269-343-56
- Packager: H2-Pharma, LLC
- 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 June 30, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
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Uses
- temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to
- eczema
- psoriasis
- insect bites
- poison ivy, oak, sumac
- detergents
- jewelry
- cosmetics
- soaps
- seborrheic dermatitis
- temporarily relieves external anal and genital itching
- other uses of this product should be only under the advice and supervision of a doctor
- temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to
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Warnings
For external use only.
Do not use
- in the genital area 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 use more than directed unless directed by a doctor
- do not put directly into the rectum by using fingers or any mechanical device or applicator
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Directions
- for itching of skin irritation, inflammation, and rashes
- 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: consult a doctor
- for external anal and genital 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
- apply to affected area not more than 3 to 4 times daily
- children under 12 years of age: consult a doctor
- for itching of skin irritation, inflammation, and rashes
- Other information
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Inactive ingredients
cetyl alcohol, citric acid1, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate solution1, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax
- 1
- Contains one or more of these ingredients to adjust pH
- Questions or comments?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
NDC 61269-343-56
†Compare to the active ingredient in
Maximum Strength Cortaid®Maximum Strength
Hydrocortisone Cream, USP 1%Anti-itch Cream
For external use only
Relieves itches and rashes
For temporary relief of: Skin irritations, inflammation, rashes | Insect bites, eczema, psoriasis | Seborrheic dermatitis
Poison ivy, oak, and sumac | External anal and genital itchingNet wt. 1 oz (28 g)
H2 pharma
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INGREDIENTS AND APPEARANCE
HYDROCORTISONE MAXIMUM STRENGTH
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61269-343 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 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) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61269-343-56 1 in 1 CARTON 06/29/2021 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 06/29/2021 Labeler - H2-Pharma, LLC (028473634)