Label: HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone ointment
- NDC Code(s): 71205-034-30
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 0472-0345
- 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 January 1, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
-
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
- •
- detergents
- •
- cosmetics
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- psoriasis
- •
- seborrheic dermatitis
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- for external genital, feminine and anal itching
- •
- 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
- •
- 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
- Inactive ingredients
- Questions?
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PRINCIPAL DISPLAY PANEL
Distributed by:
Actavis Pharma Inc.
Parsippany, NJ 07054
Relabeled by:
Proficient Rx LP
Thousand Oaks, CA 91320
Proficient Rx
NDC 71205-034-30
Compare to the active ingredient in Cortizone•10®*
Maximum Strength
Hydrocortisone Ointment, USP 1%
Anti-Itch Ointment
Relieves Itches and Rashes
Net wt. 1 oz (28g)For the temporary relief of itches and rashes due to:
• Insect Bites • Eczema • Seborrheic dermatitis
• Poison Ivy, oak & sumac -
INGREDIENTS AND APPEARANCE
HYDROCORTISONE MAXIMUM STRENGTH
hydrocortisone ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71205-034(NDC:0472-0345) 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 MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71205-034-30 1 in 1 CARTON 05/01/2018 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 not final part348 07/21/1998 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 RELABEL(71205-034)
