ROLL-ON PAIN CREAM

Manufacturer
PlanetHEMP LLC | Ion Labs, Inc.
Effective date
2020-07-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:20:22

Label at a glance#

ProductRoll-On Pain
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

Temporarily relieves minor pain associated with: arthritis sprains simple backache bruises muscle strains cramps

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain associated with:

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

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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.

SPL UNCLASSIFIED SECTION

Distributed by: planetHEMP • Pittsburgh, PA

PRINCIPAL DISPLAY PANEL - 74 ML Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - 74 ML Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78818-003-022023-04-24C16284748780-1d6a99b39-43ca-a426-e053-dadaa90af4c2ROLL-ON PAIN CREAM
78818-003-022022-01-28C16284748780-1d6a99b39-43ca-a426-e053-dadaa90af4c2ROLL-ON PAIN CREAM

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78818-00378818-003-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fa188146-31c6-bced-e053-6394a90afc9308342295-91b1-4cab-9983-a065a86ac0702023-04-24WarningsExact identifier
spl set id: 08342295-91b1-4cab-9983-a065a86ac070

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.