THERABLAST MAXIMUM RELIEF- lidocaine, menthol lotion 
Releaf Technologies LLC

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RELEAF TECHNOLOGIES (as PLD) - THERABLAST (78663-201)

ACTIVE INGREDIENT

Lidocaine 4%
Menthol 1%

PURPOSE

TOPICAL ANALGESIC

USES

For temporary relief of pain

WARNING

For external use only.


Do not use large quantities, particularly over raw surfaces or blistered areas.


When using this product avoid contact with the eyes.


Stop using 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 12 years of age and older: apply to the affected area not more than 3 to 4 times daily.
Children under 12 years of age: do not use, ask a doctor.

OTHER INFORMATION

Protect product from excessive moisture - Avoid storing in direct sunlight - Store with lid tightly closed

INACTIVE INGREDIENTS

Purified water, Caprylic/Capric Triglycerides, Butyrospermum Parkii (Shea) butter, Cetearyl alcohol, polysorbate 60, Glyceryl stearate, Cyclopentasiloxane, Dimethicone, Phenoxyethanol, Ethylhexylglycerin, me, Extract of Aloe Barbadense leaves, Extract of arnica,
Acrylamide/Sodium Acrylate Copolymer, Mineral Oil, Trideceth-6 Tocopheryl acetate, triethanol amine.

01b LBL_TheraBlast_100mL

THERABLAST  MAXIMUM RELIEF
lidocaine, menthol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78663-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 mL
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
WATER (UNII: 059QF0KO0R)  
HEMP (UNII: TD1MUT01Q7)  
SHEA BUTTER (UNII: K49155WL9Y)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA (UNII: O80TY208ZW)  
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)  
MINERAL OIL (UNII: T5L8T28FGP)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78663-201-34100 mL in 1 TUBE; Type 0: Not a Combination Product11/06/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01711/06/2023
Labeler - Releaf Technologies LLC (117532647)

Revised: 11/2023
Document Id: 0980999b-e892-3453-e063-6294a90a2e60
Set id: 09809985-3a88-9bb7-e063-6394a90a2f5f
Version: 1
Effective Time: 20231106
 
Releaf Technologies LLC