FORMULA 2 SKIN CARE- lidocaine 5% cream 
Derma Care Research Labs

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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Rectal Care

Lidocaine 5.0%

Local Anesthetic

Uses

Helps relieve the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

For external use only.

When using this product avoid contact with eyes, do not exceed recommended 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 rectal bleeding occurs, condition worsens or does not improve within 7 days, allergic reaction occurs to ingredients in this product, symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, or symptoms clear up and return within a few days.

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

Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water

Carton

FORMULA 2 SKIN CARE 
lidocaine 5% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-265
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 HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72839-265-0028 g in 1 TUBE; Type 0: Not a Combination Product03/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34603/09/2020
Labeler - Derma Care Research Labs (116817470)
Registrant - Derma Care Research Labs (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derrma Care Research Labs116817470manufacture(72839-265)

Revised: 3/2020
Document Id: a05d5e07-ae4a-38cc-e053-2a95a90abced
Set id: a05d5e07-ae4b-38cc-e053-2a95a90abced
Version: 1
Effective Time: 20200309
 
Derma Care Research Labs