Real Time Pain Relief Hemp Oil Plus

Manufacturer
Cosmetic Specialty Labs, Inc.
Effective date
2018-01-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:09:11

Label at a glance#

ProductReal Time Pain Relief Hemp Oil Plus
Active ingredientARNICA MONTANA
Label structure10 sections

Indications and uses

Temporarily relieves symptoms of muscle pain, soreness, bruising and swelling due to overexertion or injury.

Dosage and administration

Apply to affected area 2 times daily or as needed.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Arnica Montana (3X H.P.U.S.)

Purpose

OTC - PURPOSE SECTION

Bruising, Stiffness, Pain

*The letters H.P.U.S. indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Uses:

INDICATIONS & USAGE SECTION

Temporarily relieves symptoms of muscle pain, soreness, bruising and swelling due to overexertion or injury.

Warnings:

WARNINGS SECTION

for external use only

When using this product:

OTC - WHEN USING SECTION

  • Avoid contact with eyes.
  • If swallowed, get medical help or contact a Poison Control Center immediately.
  • Test for allergy by rubbing small amount on skin first.
  • Do not use if allergic to or hypersensitive to any ingredient.
  • If condition worsens or does not improve consult a doctor.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep all medicines out of reach of children.

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply to affected area 2 times daily or as needed.

Other ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Purified Water, Methylsulfonylmethane, Sorbitol, Cetearyl Alcohol, Cetyl Alcohol, SD Alcohol 40, Tocopheryl Acetate, Emu Oil, Butylene Glycol, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Phenoxyethanol, Caprylyl Glycol, Carbomer, Triethanolamine, Fragrance, Glycerin, Curcuma Longa (Tumeric) Root Extract, Wasabi Japonica Root Extract, Salix Alba (Willow) Bark Extract, Mentha Piperita (Peppermint) Leaf Oil, Industrial Hemp Seed Oil, Menthol, Extracts of: (Calendula officinalis (Marigold), Anthemis nobilis (Roman Chamomile), Tilia cordata (Lime Tree), Centaurea cyanus (Cornflower), Chamomilla recutita (Matricaria Chamomilla), Hypericum perforatum (St. John’s Wort)), Coriandrum Sativum (Coriander) Fruit Oil.

Principal Display Panel and Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelingLabeling

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-101-04Real Time Pain Relief Hemp Oil Plus114 g in 1 TUBECREAM1141
58133-101-12Real Time Pain Relief Hemp Oil Plus340 g in 1 TUBE, WITH APPLICATORCREAM3401
58133-101-15Real Time Pain Relief Hemp Oil Plus42 g in 1 TUBECREAM421

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-101REAL TIME PAIN RELIEF HEMP OIL PLUS (ARNICA MONTANA) CREAM [COSMETIC SPECIALTY LABS, INC.]1Legacy NDC, 3 package rows20180122_62d7422a-1d5a-164f-e053-2a91aa0acec7.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58133-10158133-101-04, 58133-101-12, 58133-101-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 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
62d7422a-1d5b-164f-e053-2a91aa0acec762d7422a-1d5a-164f-e053-2a91aa0acec72018-01-15WarningsExact identifier
spl id: 62d7422a-1d5b-164f-e053-2a91aa0acec7
spl set id: 62d7422a-1d5a-164f-e053-2a91aa0acec7

Reported adverse events (FAERS/openFDA)#

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