TATOO CARE- lidocaine cream 
INDUSTRIAS QUIMICAS INDEPENDENCIA SA

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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Package label

Seconday Package

Primary packaging

Active ingredients

Lidocaine 5%

Ask your doctor

If any side effect is observed, discontinue use and consult your healthcare practicioner

Do not use

Do not use if allergic to Lidocaine or other local anesthetics

Keep out of the reach of children

Keep out of the reach of children

Pregnancy or Breast feeding

Do not use if you are pregnant or breast feeding

Purpose

Topical anesthethics

Questions or comments

Call us 1-954-607-7658

Warnings

If any side effect is observed, discontinued use and consult your healthcare practicioner

Directions

Wash the specific area with soap and warm water to open pores and dry. Apply a thick and even layer of the product

Dosage and administration

Apply a thick and even layer on the area

Warnings

For external use only.

  • Before using this product perform an allergy test by applying a small amount of product on the forearm. If no side effect appear after 30 minutes, such asredness, irritation or itching, you can start applying it.
  • Keep out of the reaching of children
  • The use of this product has not been tested in areas such as eyes contours and mucus membranes.
  • Do not use if allergic to lidocaine or other local anesthetics
  • For all kind of skin
  • If any side effect is observed, discontinue use and consult your healthcare practicioner

Inactive ingredients

WATER, CAPRYLIC/CAPRIC/STEARIC TRIGLYCERIDE, GLYCERIN, C13-14 ISOPARAFFIN/LAURETH-7/POLYACRYLAMIDE, CYCLOMETHICONE, JOJOBA OIL, GLYCERYL STEARATE /PEG-100 STEARATE, CETYL ALCOHOL, GLYCERYL STEARATE SE, PHENOXYETHANOL & ETHYLHEXYLGLYCERIN, ALPHA TOCOPHEROL ACETATE, DL ALOE VERA LEAF EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, DIMETHICONE 350, EDETATE DISODIUM, SODIUM HYDROXIDE

Indications

Temporary pain relief

TATOO CARE 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83527-1001
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
WATER (UNII: 059QF0KO0R)  
LAURETH-7 (UNII: Z95S6G8201)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
JOJOBA OIL (UNII: 724GKU717M)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
CAPRYLIC/CAPRIC/PALMITIC/STEARIC TRIGLYCERIDE (UNII: ZF29F7IK5I)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83527-1001-11 in 1 BOX06/19/2023
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01506/19/2023
Labeler - INDUSTRIAS QUIMICAS INDEPENDENCIA SA (971036108)
Registrant - INDUSTRIAS QUIMICAS INDEPENDENCIA SA (971036108)
Establishment
NameAddressID/FEIBusiness Operations
INDUSTRIAS QUIMICAS INDEPENDENCIA SA971036108manufacture(83527-1001)

Revised: 6/2023
Document Id: fe43061a-be2e-e873-e053-6294a90adbe3
Set id: fdb74c89-255d-ab2b-e053-6294a90a098b
Version: 2
Effective Time: 20230616
 
INDUSTRIAS QUIMICAS INDEPENDENCIA SA