Label: ANORECTAL LIDOCAINE CREAM- lidocaine cream
- NDC Code(s): 0536-1339-28
- Packager: RUGBY LABORATORIES
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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.
Updated September 1, 2021
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- Active ingredient
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.
• 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
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1339 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1339-28 1 in 1 CARTON 09/04/2021 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 final part346 09/04/2021 Labeler - RUGBY LABORATORIES (079246066) Registrant - Strive Pharmaceuticals Inc. (080028013)