Roll-On Pain by PlanetHEMP LLC / Ion Labs, Inc. / PlanetHemp LLC ROLL-ON PAIN CREAM

Drug Details [pdf]

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

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78818-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	40 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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
Color	white (Opaque)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 78818-003-02	1 in 1 BOX	07/08/2020	06/30/2021
1		74 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/08/2020	06/30/2021

Labeler - PlanetHEMP LLC (077256475)

Name	Address	ID/FEI	Business Operations
Establishment
Ion Labs, Inc.		106499791	manufacture(78818-003)

Name	Address	ID/FEI	Business Operations
Establishment
PlanetHemp LLC		077256475	label(78818-003)

Revised: 4/2023

Document Id: fa188146-31c6-bced-e053-6394a90afc93

Set id: 08342295-91b1-4cab-9983-a065a86ac070

Version: 3

Effective Time: 20230424