PAIN RELIEVING CREAM LIDOCAINE- benzyl alcohol, lidocaine hci cream 
Trifecta Pharmaceuticals USA LLC

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Globe Pain Relieving Cream+ Lidocaine

Active Ingredient

Lidocaine HCL 4%

Purpose

Topical Anasthetic

Benzyl Alcohol 10%

Purpose

Topical Anesthetic

Uses

Temporary Pain Relief

Do Not Use

When Using this Product

Warnings

For external Use Only

Do not use

If Pregnant or Breast Feeding

Ask a health professional before use

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away

Directions

Adults and children over 12 years

Children 12 years or younger

Stop Use and Ask a Doctor If

Other Information

Inactive Ingredients

Aloe barbadensis leaf juice, aminomethyl propanol, Butylene glycol, carbome interpolymer type A (allyl sucrose crosslinked), Ceteth-10 phosphate, Cetostearyl alcohol, Dihexadecyl phosphate, Dimethicone, Glyceryl 1-stearate, Hydroxyethly acrylate/sodium acryloydimethyl taurate copolymer, maltodextrin, polysorbate 80, SD alcohol, Steareth-21, water

Distributed By

Trifecta Pharmaceuticals USA®

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Questions

Call 1-888-296-9067

4054 GLOBE LIDOCAINE 4 PERCENT PAIN RELIEF CREAM 3OZ REV09 091223 CDER

PAIN RELIEVING CREAM LIDOCAINE 
benzyl alcohol, lidocaine hci cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-139
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
STEARETH-21 (UNII: 53J3F32P58)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-139-031 in 1 BOX08/23/2023
185 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01708/23/2022
Labeler - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 11/2023
Document Id: 0ac4d57d-56ed-7dda-e063-6394a90a9a51
Set id: 039a2036-54b2-cf28-e063-6294a90a8ce6
Version: 2
Effective Time: 20231122
 
Trifecta Pharmaceuticals USA LLC