ANORECTAL- lidocaine cream 
Rite Aid

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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Drug Facts

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

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

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. • Gently dry by patting or blotting with tissue or a soft
cloth before application of this product. • 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 15-30˚ 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.

image descriptionimage description

ANORECTAL 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-1234
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) Lidocaine5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-1234-11 in 1 CARTON03/24/2016
128.3 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34603/24/2016
Labeler - Rite Aid (014578892)
Registrant - Product Quest (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest927768135manufacture(11822-1234) , label(11822-1234)

Revised: 6/2018
Document Id: 26ab8c28-c8ce-4293-ab9e-7aeb67b07aaf
Set id: 6f3d2c8f-ca2d-4ef7-b2c7-271376f97e9d
Version: 1
Effective Time: 20180618
 
Rite Aid