ANORECTAL- lidocaine cream 
Amerisource Bergen

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.

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Anorectal Cream [GNP]

Active ingredient                                 Purpose


Lidocaine 5%........................................Local Anesthetic

Uses

For temporary relief of local and anorectal discomfort associated with anorectal discomfort or inflammation.

Warnings
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.

If swallowed, get help or contact a Poison Control Center right away.

Directions

Cleanse affected area and gently dry. Apply externally to the affected area up to 6 times daily, especially at night, in the morning or after each bowel movement • Children under 12 years of age: consult a doctor.

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.

Questions?

 888-793-8450

image descriptionimage description

ANORECTAL 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-652
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46122-652-031 in 1 CARTON01/19/2021
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34601/19/2021
Labeler - Amerisource Bergen (007914906)
Establishment
NameAddressID/FEIBusiness Operations
Inspec Solutions LLC081030372manufacture(46122-652)

Revised: 1/2022
Document Id: d5cb27f7-cd53-3dfa-e053-2995a90a35c9
Set id: e66da6eb-7ee8-416d-a20f-45e5c42d47d6
Version: 3
Effective Time: 20220117
 
Amerisource Bergen