RANDEX HEMP cream

Manufacturer
Randex Trading Inc.
Effective date
2021-04-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:01

Label at a glance#

ProductRANDEX HEMP cream
Active ingredientARNICA MONTANA FLOWER, DIMETHYL SULFONE, MENTHOL
Label structure12 sections

Dosage and administration

Adults and children 12 years of age and older: ● apply generously to affected area ● massage into painful area until thoroughly absorbed into skin ● repeat as necessary ,but no more than 4 times daily . Children 12 years or younger: Consult physician.

Storage and handling

Store at room temperature with the cap closed Notice: because this product contains natural nutrients,color may vary.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

MSM 11% ............................................................. Cooling Pain Relief
Arnica montana 4.5% ...................................................... Treat Arthritis
Menthol 3.6% ............................................................ Relieves muscle

Purpose

OTC - PURPOSE SECTION

Active Ingredients Purpose
MSM 11% ............................................................. Cooling Pain Relief
Arnica montana 4.5% ...................................................... Treat Arthritis
Menthol 3.6% ............................................................ Relieves muscle

Use

INDICATIONS & USAGE SECTION

Flammab Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Warnings

WARNINGS SECTION

For external use only.

Flammab Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Stop use and ask a doctor if: Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur.

If pregnant or breast-feeding: Ask a health professional before use.

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

Do not use

OTC - DO NOT USE SECTION

● Do not use with other ointments, creams, sprays or liniments
●Do not use with heating pad or device.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if: Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur.

If pregnant or breast-feeding: Ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older:
● apply generously to affected area
● massage into painful area until thoroughly absorbed into skin
● repeat as necessary ,but no more than 4 times daily .
Children 12 years or younger: Consult physician.

Other information

STORAGE AND HANDLING SECTION

Store at room temperature with the cap closed
Notice: because this product contains natural nutrients,color may vary.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Argan oil, Jojoba oil, Emu oil, Hempseed oil, Turmeric, Aloe vera, Squalane , Beeswax, Rosmarinus Officinalis leaf oil, Benzyl alcohol, Capsaicin, Carbomer940, Purified Water.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

81852-001-01 30000mg in 1 box

81852-001-01 30000mg in 1 box81852-001-01 30000mg in 1 box

81852-001 Directions 1

81852-001 Directions 181852-001 Directions 1

81852-001 Directions 281852-001 Directions 2

81852-001 label

81852-001 label81852-001 label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81852-001-012022-07-29C16284748780-1e4f33bdf-b238-d8a0-e053-dadaa90a6e4e81852-001 RANDEX HEMP cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81852-001-01RANDEX HEMP cream30000 mg in 1 BOXCREAM300001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81852-001RANDEX HEMP CREAM CREAM [RANDEX TRADING INC.]1Legacy NDC, 1 package rows20210428_c0ff9d61-b5b3-c8b4-e053-2a95a90ab1dc.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81852-00181852-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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
c0ff9d1c-854f-6f8c-e053-2a95a90a738bc0ff9d61-b5b3-c8b4-e053-2a95a90ab1dc2021-04-27WarningsExact identifier
spl id: c0ff9d1c-854f-6f8c-e053-2a95a90a738b
spl set id: c0ff9d61-b5b3-c8b4-e053-2a95a90ab1dc

Reported adverse events (FAERS/openFDA)#

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