Label: ANORECTAL EQUATE- lidocaine cream
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Contains inactivated NDC Code(s)
NDC Code(s): 49035-655-01 - Packager: Walmart
- 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.
Drug Label Information
Updated December 29, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient Purpose
- PURPOSE
- INDICATIONS & USAGE
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Warnings
For external use only
When using this product do not get into eyes.
Stop use and ask a doctor if • condition worsens or does
not improve within 7 days • do not exceed the
recommended daily dosage unless directed by a doctor
• in case of bleeding, consult a doctor promptly • do not
put this product into the rectum by using fingers or any
mechanical device or applicator
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANORECTAL EQUATE
lidocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-655 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 mL Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) 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:49035-655-01 1 in 1 CARTON 04/16/2016 1 29.6 mL 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 04/16/2016 Labeler - Walmart (051957769) Registrant - Product Quest (927768135) Establishment Name Address ID/FEI Business Operations Product Quest 927768135 manufacture(49035-655) , label(49035-655)