RelieveIt Regenerating Gel

Manufacturer
Cosmetic Specialty Labs, Inc.
Effective date
2018-10-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:10:30

Label at a glance#

ProductRelieveIt Regenerating Gel
Active ingredientBOSWELLIA SERRATA RESIN OIL, ARNICA MONTANA, KALANCHOE PINNATA LEAF, HARPAGOPHYTUM PROCUMBENS ROOT, CALENDULA OFFICINALIS SEED OIL
Label structure12 sections

Indications and uses

• Delayed Onset muscle Soreness (DOMS) • Acute Muscle soreness • Tendonitis • Muscle pulls/ aches /soreness/ strains • Joint pain/ discomfort

Dosage and administration

Adults and children 2 years and over: •Shake well before using •Apply a sufficient amount of RelieveIt® Regenerating Gel to cover the affected area • Repeat as needed • After applying, wash hands with soap and water Children under 2: consult a doctor

Storage and handling

Store at 68-77°F (20-25°C)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Arnica montana 1X: 7%

Calendula officinalis 6X: 2%

Boswellia serrata: 2%

Harpagophytum procumbens(Devil's Claw): 5%

Kalanchoe Pinnata (Wonder of the World): 2%

Purpose

OTC - PURPOSE SECTION

For recovery from muscle aches, fatigue and soreness.

Uses:

INDICATIONS & USAGE SECTION

• Delayed Onset muscle Soreness (DOMS)

• Acute Muscle soreness • Tendonitis

• Muscle pulls/ aches /soreness/ strains

• Joint pain/ discomfort

Warnings:

WARNINGS SECTION

for external use only

When using this product:

OTC - WHEN USING SECTION

use only as directed • avoid contact with eyes

or mucous membranes • do not apply to open

wounds, damaged, or very sensitive skin • do

not use if you are allergic to any of this product’s

active or inactive ingredients • do not apply

bandage tightly or use heating pad • do not

resume normal activity without the advice of a

  • medical professionall

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact the

Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years and over:

•Shake well before using •Apply a sufficient

amount of RelieveIt® Regenerating Gel to cover the

affected area • Repeat as needed • After

applying, wash hands with soap and water

Children under 2: consult a doctor

Other ingredients:

INACTIVE INGREDIENT SECTION

Carbomer 934P, Cyclomethicone, Ethyl Alcohol,
Eucalyptus Oil, Glycerin, Hydroxypropyl Cellulose,
C13/14 Isoparaffin, Isopropyl Myristate, Juniper
Oil, Laureth-7, Polyacrylamide, Polyethylene
Glycol 3350, Polysorbate 80, Propyl Gallate,
Propylene Glycol, Purified Water, Resin, Sodium
Hydroxide, Sorbic Acid, Wintergreen Oil,
Xanthan Gum.

*These “Uses” have not been evaluated by the
Food & Drug Administration.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

excessive redness or irritation is present •

condition worsens • pain persists for more than

7 days

If pregnant or breast feeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Other Information

STORAGE AND HANDLING SECTION

Store at 68-77°F (20-25°C)

Principal Display Panel and Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58133-952-162024-01-30C16284748780-11030e365-6c64-111a-e063-dadaa90a10e2RelieveIt Regenerating Gel
58133-952-372024-01-30C16284748780-11030e365-6c64-111a-e063-dadaa90a10e2RelieveIt Regenerating Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-952-16RelieveIt Regenerating Gel474 mL in 1 BOTTLE, PUMPGEL4742
58133-952-37RelieveIt Regenerating Gel3780 mL in 1 BOTTLE, PUMPGEL37802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-952RELIEVEIT REGENERATING GEL (ARNICA MONTANA, CALENDULA OFFICINALIS, BOSWELLIA SERRATA, HARPAGOPHYTUM PROCUMBENS, KALANCHOE PINNATA) GEL [COSMETIC SPECIALTY LABS, INC.]2Legacy NDC, 2 package rows20181023_787129c2-724d-d190-e053-2a91aa0ac6ff.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
58133-95258133-952-16, 58133-952-37

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
78d37379-7715-c444-e053-2a91aa0a789b787129c2-724d-d190-e053-2a91aa0ac6ff2018-10-22WarningsExact identifier
spl id: 78d37379-7715-c444-e053-2a91aa0a789b
spl set id: 787129c2-724d-d190-e053-2a91aa0ac6ff

Reported adverse events (FAERS/openFDA)#

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