Real Time Pain Relief Select Plus Hemp Oil

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 Select Plus Hemp Oil
Active ingredientARNICA MONTANA
Label structure11 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, Butylene Glycol, Hamamelic Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Rubus Idaeus (Raspberry) Seed Oil, Phenoxyethanol, Caprylyl Glycol, Fragrance, Carbomer, Triethanolamine, Salix Alba (Willow) Bark Extract, Industrial Hemp Seed Oil, Menthol, Capsicum Frutescens Fruit, Calendula officinalis (Marigold), Anthemis nobilis (Roman Chamomile), Tilia cordata (Lime Tree), Centaurea cyanus (Cornflower), Chamomilla recueta (Matricaria Chamomilla), Hypericum perforatum (St. John’s Wort), Coriandrum Saevum (Coriander) Fruit Oil.

SPL UNCLASSIFIED SECTION

There is no scientific evidence that homeopathic products work. The product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.

100% VEGAN

Principal Display Panel and Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelingLabeling

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58133-800-032024-01-30C16284748780-11030e365-21d8-111a-e063-dadaa90a10e2Real Time Pain Relief Select Plus Hemp Oil

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-800-03Real Time Pain Relief Select Plus Hemp Oil88 mL in 1 BOTTLE, WITH APPLICATORLOTION881

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-800REAL TIME PAIN RELIEF SELECT PLUS HEMP OIL (ARNICA MONTANA) LOTION [COSMETIC SPECIALTY LABS, INC.]1Legacy NDC, 1 package rows20180122_62d5d892-c013-7905-e053-2991aa0a9ba6.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58133-80058133-800-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 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
62d5d892-c014-7905-e053-2991aa0a9ba662d5d892-c013-7905-e053-2991aa0a9ba62018-01-15WarningsExact identifier
spl id: 62d5d892-c014-7905-e053-2991aa0a9ba6
spl set id: 62d5d892-c013-7905-e053-2991aa0a9ba6

Reported adverse events (FAERS/openFDA)#

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