Label: ANORECTAL- lidocaine cream
- NDC Code(s): 46122-652-03
- Packager: Amerisource Bergen
- 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 January 17, 2022
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- Active ingredient Purpose
For external use only.
When using this product • do not get into eyes. • do not exceed the recommended daily 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 • condition worsens or does not improve within 7 days. • in case of bleeding, consult a doctor promptly • Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.
If pregnant or breastfeeding, ask a health professional before use.
- Keep out of reach of children.
- Other Information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46122-652 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 5 g in 100 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOMER 940 (UNII: 4Q93RCW27E) CHOLESTEROL (UNII: 97C5T2UQ7J) 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 ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46122-652-03 1 in 1 CARTON 01/19/2021 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 01/19/2021 Labeler - Amerisource Bergen (007914906) Establishment Name Address ID/FEI Business Operations Inspec Solutions LLC 081030372 manufacture(46122-652)