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NDC 00536-1339-28 ANORECTAL Lidocaine Cream 50 mg/g Details
ANORECTAL Lidocaine Cream 50 mg/g
ANORECTAL Lidocaine Cream is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by RUGBY LABORATORIES. The primary component is LIDOCAINE.
Product Information
| NDC | 00536-1339 |
|---|---|
| Product ID | 0536-1339_c98bfc2d-abb3-4bc3-b824-83e52f1bf0d8 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | ANORECTAL Lidocaine Cream |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Lidocaine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/g |
| Substance Name | LIDOCAINE |
| Labeler Name | RUGBY LABORATORIES |
| Pharmaceutical Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part346 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00536-1339-28 (00536133928)
| NDC Package Code | 0536-1339-28 |
|---|---|
| Billing NDC | 00536133928 |
| Package | 1 TUBE in 1 CARTON (0536-1339-28) / 28 g in 1 TUBE |
| Marketing Start Date | 2021-09-04 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL bfeafe34-f502-4cbe-9197-4980100848da Details
Uses
Warnings
For external use only
When using this product
• avoid contact with eyes
• do not exceed recommended dosage unless directed by a doctor
• do not put this product into the rectum by using fingers or any mechanical device or applicator
Stop use and ask a doctor if
• rectal bleeding occurs
• condition worsens or does not improve within 7 days
• allergic reaction occurs to ingredients in this product
• symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
• symptoms clear up and return within a few days
If pregnant or breast feeding, ask a health professional before use.
Directions
• When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying .
• Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
• Children under 12 years of age: consult a doctor.
Other information
Inactive ingredients
SPL UNCLASSIFIED SECTION
Compare to the active ingredient in Recticare® Anorectal Cream††
• For the temporary relief of anorectal itching & discomfort associated with hemorrhoids
• Helps relieve pain, soreness & burning
• Highest OTC lidocaine strength available
+ 10 FINGER COTS*
READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
TAMPER EVIDENT: DO NOT USE IF THE TUBE IS DAMAGED OR TAMPERED WITH.
Close cap tightly after each use.
††This product is not manufactured or distributed by Ferndale Healthcare®, Inc., a subsidiary of Ferndale Pharma Group, Inc., owner of the registered trademark RectiCare®.
INGREDIENTS AND APPEARANCE
| ANORECTAL LIDOCAINE CREAM
lidocaine cream |
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| Labeler - RUGBY LABORATORIES (079246066) |
| Registrant - Strive Pharmaceuticals Inc. (080028013) |