{"active_ingredient":["Lidocaine 4%."],"dosage_and_administration":["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. For the temporary relief of pain and discomfort associated with anorectal disorders."],"effective_time":"20260215","id":"49a1dc60-72e9-c233-e063-6394a90ac282","inactive_ingredient":["Inactive Ingredients Water, Glycerin, Propylene Glycol, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Caprylic/ Capric Triglyceride, Tocopheryl Acetate, Arginine, Phenoxyethanol, Chlorphenesin"],"indications_and_usage":["Uses Helps relieve the pain, itching and burning associated with hemorrhoids and other anorectal disorders. 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 breastfeeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M017"],"brand_name":["RelaxInk LIDOCAINE"],"generic_name":["LIDOCAINE 4%"],"is_original_packager":[true],"manufacturer_name":["Hambli Limited"],"nui":["N0000175682","M0000897","N0000175426","N0000175976"],"package_ndc":["83714-0004-0","83714-0004-1"],"pharm_class_cs":["Amides [CS]"],"pharm_class_epc":["Amide Local Anesthetic [EPC]","Antiarrhythmic [EPC]"],"pharm_class_pe":["Local Anesthesia [PE]"],"product_ndc":["83714-0004"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1421893"],"spl_id":["49a1dc60-72e9-c233-e063-6394a90ac282"],"spl_set_id":["49a1cf66-9bb1-b918-e063-6394a90a2ff6"],"substance_name":["LIDOCAINE"],"unii":["98PI200987"]},"package_label_principal_display_panel":["DRUG FACTS DRUG FACTS Active Ingredient Lidocaine 4%. Uses Helps relieve the pain, itching and burning associated with hemorrhoids and other anorectal disorders. 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 breastfeeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Purpose Local anesthetic DRUG FACTS (Continued) 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. To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area. Other Information Store at 25°C (77°F); excursions permitted to 15-30C (59-86°F) [see USP Controlled Room Temperature]. Inactive Ingredients Water, Glycerin, Propylene Glycol, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Caprylic/ Capric Triglyceride, Tocopheryl Acetate, Arginine, Phenoxyethanol, Chlorphenesin Package Label Principal Display Panel"],"pregnancy":["Pregnancy Section Consult your doctor before using it"],"purpose":["Local anesthetic"],"recent_major_changes":["No change yet No change yet"],"set_id":"49a1cf66-9bb1-b918-e063-6394a90a2ff6","spl_product_data_elements":["RelaxInk LIDOCAINE LIDOCAINE 4% CHLORPHENESIN GLYCERIN CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE PHENOXYETHANOL ARGININE .ALPHA.-TOCOPHEROL ACETATE, D- WATER HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) PROPYLENE GLYCOL LIDOCAINE LIDOCAINE"],"version":"1","warnings":["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 breastfeeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."]}