LIDOCAINE- lidocaine cream 
Stratus Pharmaceuticals Inc

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Lidocaine 4% Cream

Drug Facts

Active ingredient

Lidocaine 4% (4g in 100g)

Purpose

Local analgesic

Uses

for the temporary relief of pain and itching associated with

Warnings

For external use only

When using this product

  • avoid contact with the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas

Stop use and consult a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Lidocaine is NOT approved by FDA to treat teething pain and should NOT be given to infants and young children for this use.

If pregnant or breast-feeding

Ask a health professional before use.

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

Directions

Other information

Store at 20°C to 25°C (68°F to 77°F)

Inactive ingredients

acrylamide, allantoin, aloe vera extract, benzyl alcohol, c12-15 alkyl benzoate, carbomer, isohexadecane, polysorbate 80, propylene glycol, purified water, sodium acryloydimethyl taurate, sodium laureth sulfate, soy lecithin, tocopheryl acetate.

Questions?

Call us at (800) 442-7882

Distributed by:
Stratus Pharmaceuticals Inc.
Miami, FL 33186

PRINCIPAL DISPLAY PANEL - 28.35 g Tube Box

STRATUS
PHARMACEUTICALS INC

NDC 58980-824-30

Net WT. 1 oz. / 28.35 g

LIDOCAINE CREAM
4%

PAIN RELIEVING CREAM

FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE

PRINCIPAL DISPLAY PANEL - 28.35 g Tube Box
LIDOCAINE 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58980-824
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987) Lidocaine40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Acrylamide (UNII: 20R035KLCI)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
Allantoin (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Benzyl Alcohol (UNII: LKG8494WBH)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
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:58980-824-301 in 1 BOX02/15/2024
128.35 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM01702/15/2024
Labeler - Stratus Pharmaceuticals Inc (789001641)
Establishment
NameAddressID/FEIBusiness Operations
Tarmac Products Inc059890491MANUFACTURE(58980-824)

Revised: 1/2024
Document Id: 6d7d2bd4-a498-49bd-b4b8-a74f0a77ce1b
Set id: e1a8d4a7-01f7-4bab-8d09-875c461b3b61
Version: 1
Effective Time: 20240118
 
Stratus Pharmaceuticals Inc