LIDOCAINE- lidocaine cream 
STRATUS PHARMACEUTICALS INC

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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LIDOCAINE 5% CREAM

Drug Facts

Active Ingredient

Lidocaine 5% w/w

Purpose

Local anesthetic

Uses

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

WARNINGS

"Methemoglobinemia Warning" use of this product may cause; a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used the product before. Stop use and seek immediate medical attention if the following develops: pale, gray, or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, fatigue or lack of energy. If pregnant or breast feeding, ask a health provider before use.

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

Directions

When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying. Adults and children 12 years and older: apply externally to the affected area up to 6 times a day. 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) [see USP Controlled Room Temperature].

Inactive Ingredients

acrylamide, allantoin, aloe vera extract, benzyl alcohol, C12-15 alkyl benzoate, carbomer, isohexadecane, polysorbate 80, propylene glycol, purified water, sodium acryloyldimethyl taurate, sodium laureth sulfate, soy lecithin and tocopheryl acetate.

Distributed By: Stratus Pharmaceuticals, Inc.,Miami, FL 33186

PRINCIPAL DISPLAY PANEL - 14.17 g Tube Box

STRATUS
PHARMACEUTICALS INC

NDC 58980-823-05

Net WT. 0.5 oz. / 14.17 g

LIDOCAINE CREAM
5%

ANORECTAL CREAM

PRINCIPAL DISPLAY PANEL - 14.17 g Tube Box
LIDOCAINE 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58980-823
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ACRYLAMIDE (UNII: 20R035KLCI)  
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM ACRYLOYLDIMETHYLTAURATE (UNII: 2T9Q6EKI0G)  
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58980-823-301 in 1 BOX08/12/2019
128.35 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:58980-823-051 in 1 BOX12/18/2023
214.17 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34608/12/2019
Labeler - STRATUS PHARMACEUTICALS INC (789001641)
Establishment
NameAddressID/FEIBusiness Operations
TARMAC PRODUCTS INC059890491MANUFACTURE(58980-823)

Revised: 9/2023
Document Id: c07360a1-780f-4ddc-b44f-dd1984ddb15b
Set id: 87a4f559-a4f6-4b9f-98de-b55b073a11c6
Version: 4
Effective Time: 20230913
 
STRATUS PHARMACEUTICALS INC