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Anorectal Equate

Medically reviewed on December 29, 2017

Dosage form: cream
Ingredients: LIDOCAINE 5g in 100mL
Labeler: Walmart
NDC Code: 49035-655

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 Facts FR#44-61PQ

Active ingredient                               Purpose


Lidocaine 5%......................................Local anesthetic

Uses For temporary relief of pain, soreness and burning.

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

Keep out of reach of children. If swallowed, get medical
help or contact a Poison Control Center right away.

Directions Apply externally to affected area up to 6
times daily.

Other information Store at 25° C (77° F);
excursions permitted to 15-30˚ C (59-86˚ F).

Inactive ingredients
Benzyl Alcohol, Carbomer 940, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, Vitamin E Acetate.

ANORECTAL   EQUATE
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-655
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
CHOLESTEROL 
HYDROGENATED SOYBEAN LECITHIN 
ISOPROPYL MYRISTATE 
POLYSORBATE 80 
PROPYLENE GLYCOL 
WATER 
TROLAMINE 
.ALPHA.-TOCOPHEROL ACETATE 
Packaging
#Item CodePackage Description
1NDC:49035-655-011 TUBE in 1 CARTON
129.6 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34604/16/2016
Labeler - Walmart (051957769)
Registrant - Product Quest (927768135)
Establishment
NameAddressID/FEIOperations
Product Quest927768135manufacture(49035-655), label(49035-655)

 
Walmart

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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