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NDC 63187-0567-01 Hydrocortisone Maximum Strength with Aloe 1 g/100g Details
Hydrocortisone Maximum Strength with Aloe 1 g/100g
Hydrocortisone Maximum Strength with Aloe is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is HYDROCORTISONE.
MedlinePlus Drug Summary
Hydrocortisone topical is used to treat redness, swelling, itching, and discomfort of various skin conditions. Hydrocortisone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
Related Packages: 63187-0567-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical
Product Information
NDC | 63187-0567 |
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Product ID | 63187-567_aa75144e-e1b4-4a63-ae25-d3d3a18513de |
Associated GPIs | 90550075003720 |
GCN Sequence Number | 016266 |
GCN Sequence Number Description | hydrocortisone/aloe vera CREAM (G) 1 % TOPICAL |
HIC3 | Q5P |
HIC3 Description | TOPICAL ANTI-INFLAMMATORY STEROIDAL |
GCN | 92421 |
HICL Sequence Number | 003289 |
HICL Sequence Number Description | HYDROCORTISONE/ALOE VERA |
Brand/Generic | Generic |
Proprietary Name | Hydrocortisone Maximum Strength with Aloe |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Hydrocortisone |
Product Type | HUMAN OTC DRUG |
Dosage Form | CREAM |
Route | TOPICAL |
Active Ingredient Strength | 1 |
Active Ingredient Units | g/100g |
Substance Name | HYDROCORTISONE |
Labeler Name | Proficient Rx LP |
Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part348 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 63187-0567-01 (63187056701)
NDC Package Code | 63187-567-01 |
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Billing NDC | 63187056701 |
Package | 1 TUBE in 1 CARTON (63187-567-01) / 28 g in 1 TUBE |
Marketing Start Date | 2018-12-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 14bd6309-ee5e-4425-81fc-943ee38451c4 Details
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
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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
Do not use
When using this product
Stop use and ask a doctor if
Keep out of reach of children.
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
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.
PRINCIPAL DISPLAY PANEL
MAJOR®
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
· Detergents
03390311B1 VC110479 Rev 06/11
INGREDIENTS AND APPEARANCE
HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE
hydrocortisone cream |
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Labeler - Proficient Rx LP (079196022) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Proficient Rx LP | 079196022 | REPACK(63187-567) , RELABEL(63187-567) |