PAIN ITCH RELIEF- lidocaine hci cream 
Trifecta Pharmaceutical USA LLC

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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Globe Maximum Strength Pain & Itch Relief Cream

DRUG FACTS

Active Ingredient

Lidocaine HCI 4%

Purpose

Topical Anesthetic

Uses

Temporarily relieves minor pain

Warnings

For external use only.

When using this product

Use only as directed.

Do not allow contact with eyes.

Do not bandage or apply local heat such as heating pads to the area of use

Do Not Use

On large areas of the body or on cut, irritated or swollen skin

On puncture wounds

For more than one week without consulting a doctor

If Pregnant or Breast Feeding

Ask a health professional before use.

Stop Use and ask a Doctor if:

Keep out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Adults and children over 12 years:

Apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period.

Children 12 years or younger: ask a doctor

Questions

For Questions please call 1 888 296 9067

Other Information

Store at room temperature

Inactive Ingredient:

Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl Sterate, Light Mineral Oil, Petrolatum, Polyoxyethylene Lauryl Ether, Purified Water, Sodium Lauryl Sulfate.

Distributed By

Trifecta Pharmaceuticals USA

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

This product is not manufactured or distributed by Chattem, Inc. a Sanofi Company owner of the registered trademark Gold Bond.

Packaging

Globe Lidocaine Cream 49.6g CDER

PAIN ITCH RELIEF 
lidocaine hci cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-120
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
Inactive Ingredients
Ingredient NameStrength
STEARETH-21 (UNII: 53J3F32P58)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CYCLOMETHICONE 7 (UNII: KCK5L8VU47)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
WATER (UNII: 059QF0KO0R)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-120-171 in 1 BOX01/06/2023
149.6 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/06/2023
Labeler - Trifecta Pharmaceutical USA LLC (079424163)

Revised: 2/2023
Document Id: f40b19a8-795d-f514-e053-2a95a90a6d15
Set id: f40b19a8-795c-f514-e053-2a95a90a6d15
Version: 1
Effective Time: 20230206
 
Trifecta Pharmaceutical USA LLC