Raw Heat

Manufacturer
Raw Health International, LLC | Safetec of America, Inc.
Effective date
2013-01-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:34:23

Label at a glance#

ProductRaw Heat
Active ingredientmenthol
Label structure9 sections

Indications and uses

Temporarily relieves minor pain associated with: muscle sprains, muscle strains, neck/back aches/pains, sore joints, arthritis, cramps and bruises.

Dosage and administration

For adults and children 6 years of age and older: Shake well. Clean skin. Apply a liberal amount of gel directly on the skin over the affected area until absorbed into skin. Repeat as necessary, but not more than 4 times daily. May also be applied before or after activity. For children under 6 years of age, consult a health care professional.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 3.5%

Purpose

OTC - PURPOSE SECTION

Pain Reliever

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain associated with: muscle sprains, muscle strains, neck/back aches/pains, sore joints, arthritis, cramps and bruises.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from open flame or extreme heat.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed get medical help or contact a poison control center right away.

OTC - WHEN USING SECTION

When using this product: Use only as directed. Avoid contact with eyes and mucous membranes. Do not apply to open wounds or damaged skin. Do not bandage tightly.

OTC - DO NOT USE SECTION

Do not use with a heating pad or other ointments, creams, sprays or liniments. Do not apply to irritated skin. Wash hands thoroughly after each application.

OTC - STOP USE SECTION

Stop use and ask a health professional if condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, or if irritation occurs. If pregnant or breast feeding ask a health care professional before use. Store at room temperature.

Directions

DOSAGE & ADMINISTRATION SECTION

For adults and children 6 years of age and older: Shake well. Clean skin. Apply a liberal amount of gel directly on the skin over the affected area until absorbed into skin. Repeat as necessary, but not more than 4 times daily. May also be applied before or after activity. For children under 6 years of age, consult a health care professional.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis (Aloe) Leaf Gel, SDA 38B, Glycerin, Xanthan Gum, Gaultheria Procumbens (Wintergreen) Leaf Oil, Cinnamomum Cassia (Cassia) Oil, Dehydroxyxanthan Gum, Cinnamomum Camphora (Camphor) Bark Oil, Organic Chamomilla Recutita (Matricaria), Organic Symphytum Officinalis (Comfrey)

RAW Health International, LLC
91 Ft. Couch Road-Pittsburgh, PA 15241
www.rawhealthintl.com
Ph: 1-888-RAW-HLTH

Questions or comments:

OTC - QUESTIONS SECTION

Email us at: info@rawhealthintl.com

MSRP $14.99

PRINCIPAL DISPLAY PANEL – 3 oz. bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RAW
RAW HEALTH INTERNATIONAL

HEAT

The All-Natural
Warming Pain Reliever

Muscle Strains,
Joint Sprains, Neck/Back Aches,
Pains and Much More…

3 fl OZ / 89 mL

www.rawhealthintl.com
Also Try RAW-ICE for cooling pain relief

PRINCIPAL DISPLAY PANEL – 3 oz. bottle
PRINCIPAL DISPLAY PANEL – 3 oz. bottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
808955menthol 3.5 % Topical GelPSN2
808955menthol 0.035 MG/MG Topical GelSCD2
808955menthol 3.5 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55413-2501-1Raw Heat0.089 L in 1 BOTTLELIQUID0.0892
55413-2501-2Raw Heat0.118 L in 1 BOTTLELIQUID0.1182
55413-2501-3Raw Heat0.004 L in 1 PACKETLIQUID0.0042

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55413-2501RAW HEAT (MENTHOL) LIQUID [RAW HEALTH INTERNATIONAL, LLC]2Legacy NDC, 3 package rows20130131_cbad9b68-12e8-4766-893b-a0ed6b1f0484.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
mentholACTIVE INGREDIENTL7T10EIP3A2
mentholACTIVE MOIETYL7T10EIP3A2
aloe vera leafINACTIVE INGREDIENTZY81Z83H0X2
camphor oilINACTIVE INGREDIENT75IZZ8Y7272
chinese cinnamon oilINACTIVE INGREDIENTA4WO0626T52
glycerinINACTIVE INGREDIENTPDC6A3C0OX2
matricaria recutitaINACTIVE INGREDIENTG0R4UBI2ZZ2
methyl salicylateINACTIVE INGREDIENTLAV5U5022Y2
symphytum uplandicum leafINACTIVE INGREDIENTD05HXK6R3G2
xanthan gumINACTIVE INGREDIENTTTV12P4NEE2

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55413-250155413-2501-1, 55413-2501-2, 55413-2501-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 112 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
glycerinGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEEFILM, SOLUBLE / ORAL1 mgExact identifier — unii candidate
29 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEETABLET, EXTENDED RELEASE / ORAL528 mgExact identifier — unii candidate
29 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEETABLET / ORAL56 mgExact identifier — unii candidate
29 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEELOZENGE / ORAL1264 mgExact identifier — unii candidate
29 equally ranked IID candidates
methyl salicylateMETHYL SALICYLATELAV5U5022YTABLET / ORAL10 mgExact identifier — unii candidate
8 equally ranked IID candidates
methyl salicylateMETHYL SALICYLATELAV5U5022YPOWDER, DENTIFRICE / DENTALNAExact identifier — unii candidate
8 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
methyl salicylateMETHYL SALICYLATELAV5U5022YDOUCHE / VAGINAL0.05 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEEPOWDER, FOR SUSPENSION / ORAL600 mgExact identifier — unii candidate
29 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING / ORAL0.15 mgExact identifier — unii candidate
29 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEEENEMA / RECTAL150 mgExact identifier — unii candidate
29 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEEPOWDER, FOR SOLUTION / ORAL10 mg/5mlExact identifier — unii candidate
29 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESUSPENSION/ DROPS / ORAL22 mgExact identifier — unii candidate
29 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESOLUTION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
methyl salicylateMETHYL SALICYLATELAV5U5022YPOWDER / TOPICALNAExact identifier — unii candidate
8 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEEPOWDER / ORAL275 mgExact identifier — unii candidate
29 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
methyl salicylateMETHYL SALICYLATELAV5U5022YPASTE, DENTIFRICE / DENTAL1.1 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEETABLET, FILM COATED / ORAL0.08 mgExact identifier — unii candidate
29 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEEGEL / TOPICAL58 mgExact identifier — unii candidate
29 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates

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
d851dba4-b008-4343-a4ea-66dd8a981177cbad9b68-12e8-4766-893b-a0ed6b1f04842013-01-30WarningsExact identifier
spl id: d851dba4-b008-4343-a4ea-66dd8a981177
spl set id: cbad9b68-12e8-4766-893b-a0ed6b1f0484

Reported adverse events (FAERS/openFDA)#

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