Real Time Pain Relief Daily Relief

Manufacturer
Cosmetic Specialty Labs, Inc.
Effective date
2018-01-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:09:08

Label at a glance#

ProductReal Time Pain Relief Daily Relief
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 a needed.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Arnica Montana (2X H.P.U.S.)

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

Purpose

OTC - PURPOSE SECTION

Bruising, Stiffness, Pain

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

Warnings and Precautions

WARNINGS AND PRECAUTIONS SECTION

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

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 a needed.

Other Ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Methylsulfonylmethane, Sorbitol, Cetearyl Alcohol, SD Alcohol40, Cetyl Alcohol, Carbomer, Butylene Glycol, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Emu Oil, Phenoxyethanol, Caprylyl Glycol, Triethanolamine, Gycerin, Myristica Fragrans (Nutmeg) Extract, Fragrance, Diazolidinyl Urea, Salix Alba (Willow) Bark Extract, Aloe Barbadensis Leaf Juice, Menthol, Extracts of: (Calendula officianlis (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.

Package Label, Principal Display Panel and Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-300-04Real Time Pain Relief Daily Relief120 mL in 1 TUBELOTION1201
58133-300-12Real Time Pain Relief Daily Relief345 mL in 1 BOTTLE, PUMPLOTION3451
58133-300-15Real Time Pain Relief Daily Relief45 mL in 1 TUBELOTION451

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-300REAL TIME PAIN RELIEF DAILY RELIEF (ARNICA MONTANA (2X H.P.U.S.)) LOTION [COSMETIC SPECIALTY LABS, INC.]1Legacy NDC, 3 package rows20180108_61e590d9-f6f4-bf71-e053-2991aa0a534d.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58133-30058133-300-15, 58133-300-04, 58133-300-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 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
61e590d9-f6f5-bf71-e053-2991aa0a534d61e590d9-f6f4-bf71-e053-2991aa0a534d2018-01-03WarningsExact identifier
spl id: 61e590d9-f6f5-bf71-e053-2991aa0a534d
spl set id: 61e590d9-f6f4-bf71-e053-2991aa0a534d

Reported adverse events (FAERS/openFDA)#

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