SERA RELIEF ULTIMATE RAPID SOOTHING CREME- lidocaine hcl cream 
Sera Labs, Inc., The

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.

----------

SERA RELIEF ULTIMATE RAPID SOOTHING CREME

Drug Facts

Active Ingredients

Lidocaine 4%

Purpose

Topical Analgesic

Uses: Temporarily relief from minor pain associated with: • arthritis • bruises • simple backache • muscle strains • cramps • sprains

Warning: For external use only
Flammable: Keep away from excessive heat or open flame

When using this product: Avoid contact with eyes or mucous membrane. Do not apply to wounds, damaged, blistered or irritated skin. Do not use with other ointments, creams, sprays or liniments. Do not bandage. Wash hands after use with cool water. Do not use with heating pad or device.

Ask a doctor before use if you have sensitive skin. Stop use if condition worsens or persists for more than 7 days.

If pregnant or breast feeding: ask doctor before using

Keep out of reach of children: if accidentally ingested get medical help or contact a Poison Control Center immediately

Recommended Use: Adults, with container rub a thin film over affected areas, not more than 3-4 times in 24 hour period, massage is not necessary.

Other information: store in cool dry place

Inactive Ingredients: Allantoin, Caprylic/Capric Triglyceride, Capsicum Annuum Fruit powder, Calcium Disodium EDTA, Cannabis Sativa (Aerial) Extract Oil, DL-Alpha Tocopheryl Acetate, Ethyl Alcohol, Ethylhexylglycerin, Ethylhexyl Stearate, Glycerin, Phenoxyethanol, Polysorbate 80, Propanediol, Propylene Glycol, Purified Water, Simethicone, Sodium Polyacrylate, Trideceth-6, Vitis Vinifera (Grape) seed Oil, Xanthan Gum, Beta – Caryophyllene

Feet & Legs

4% LIDOCAINE

WITH CBD 300mg

Packaging

final

SERA RELIEF ULTIMATE RAPID SOOTHING CREME 
lidocaine hcl cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73385-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PAPRIKA (UNII: X72Z47861V)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP (UNII: 8X454SZ22D)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
ALCOHOL (UNII: 3K9958V90M)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPANEDIOL (UNII: 5965N8W85T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARYOPHYLLENE (UNII: BHW853AU9H)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73385-104-6073 mL in 1 BOTTLE; Type 0: Not a Combination Product11/04/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/04/2019
Labeler - Sera Labs, Inc., The (116914405)

Revised: 10/2019
Document Id: ae7de482-afd8-4ba5-bc5f-d520f3a7e64d
Set id: b33a3a3e-195a-42ae-8e70-cfc859376736
Version: 1
Effective Time: 20191025
 
Sera Labs, Inc., The