ROLL-ON PAIN- lidocaine hydrochloride cream 
PlanetHEMP 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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ROLL-ON PAIN CREAM

Drug Facts

Active Ingredients

Lidocaine 4%

Purpose

Topical Analgesic

Uses

Temporarily relieves minor pain associated with:

  • arthritis
  • sprains
  • simple backache
  • bruises
  • muscle strains
  • cramps

Warnings

For external use only

When using this product

  • use only as directed
  • do not bandage tightly
  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not use in large quantities, particularly over raw surfaces or blistered areas.

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

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: Consult a doctor.

Inactive Ingredients

Allantoin, Caprylic/Capric Triglyceride, Capsicum Annuum Fruit Powder, Calcium Disodium EDTA, Cannabis Sativa (Aerial) Extract Oil, Dimethicone, dl-alpha Tocopheryl Acetate, Ethyl Alcohol, Ethylhexylglycerin, Ethylhexyl Stearate, Fragrance, Glycerin, Phenoxyethanol, Polysorbate 80, Propanediol, Propylene Glycol, Purified Water, Simethicone, Sodium Polyacrylate, Trideceth-6, Vitis Vinifera (Grape) Seed Oil, Xanthan Gum.

Distributed by: planetHEMP • Pittsburgh, PA

PRINCIPAL DISPLAY PANEL - 74 ML Bottle Label

pH

ROLL-ON PAIN CREAM

4% LIDOCAINE
WITH CBD FROM INDUSTRIAL HEMP

PLANETHEMP
74ML - 2.5 FL. OZ.

PRINCIPAL DISPLAY PANEL - 74 ML Bottle Label
ROLL-ON PAIN 
lidocaine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78818-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PAPRIKA (UNII: X72Z47861V)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
CANNABIS SATIVA FLOWERING TOP (UNII: 8X454SZ22D)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.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)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARYOPHYLLENE (UNII: BHW853AU9H)  
Product Characteristics
Colorwhite (Opaque) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78818-003-021 in 1 BOX07/08/202006/30/2021
174 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/08/202006/30/2021
Labeler - PlanetHEMP LLC (077256475)
Establishment
NameAddressID/FEIBusiness Operations
Ion Labs, Inc.106499791manufacture(78818-003)
Establishment
NameAddressID/FEIBusiness Operations
PlanetHemp LLC077256475label(78818-003)

Revised: 4/2023
 
PlanetHEMP LLC