Ice

Manufacturer
Safetec of America, Inc | Safetec of America, Inc.
Effective date
2014-08-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:34:22

Label at a glance#

ProductIce
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: 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. 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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: 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 SDA 38B, Glycerin, Xanthan Gum, Mentha Piperita (Peppermint) Oil, Dehydroxyxanthan Gum, Cinnamomum Camphora (Camphor) Bark Oil, Organic Chamomilla Recutita (Matricaria) Flower Extract, Organic Symphytum Officinalis (Comfrey)

Principal Display Panel - Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safetec

ICE

Pain Relieving
Muscle Rub

Calms arthritis
Eases back aches
Relieves joint sprains

mild mint gel

100 Packets, 4 mL Each

Principal Display Panel - Carton Label
Principal Display Panel - Carton Label

Principal Display Panel - Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safetec

ICE

Pain Relieving
Muscle Rub

Calms arthritis
Eases back aches
Relieves joint sprains

mild mint gel

Net 16 fluid oz. / 473 mL

Principal Display Panel - Bottle Label
Principal Display Panel - Bottle Label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
mentholACTIVE INGREDIENTL7T10EIP3A3
mentholACTIVE MOIETYL7T10EIP3A3
aloe vera leafINACTIVE INGREDIENTZY81Z83H0X3
camphor oilINACTIVE INGREDIENT75IZZ8Y7273
glycerinINACTIVE INGREDIENTPDC6A3C0OX3
matricaria recutitaINACTIVE INGREDIENTG0R4UBI2ZZ3
peppermint oilINACTIVE INGREDIENTAV092KU4JH3
symphytum uplandicum leafINACTIVE INGREDIENTD05HXK6R3G3
xanthan gumINACTIVE INGREDIENTTTV12P4NEE3

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61010-125061010-1250-1, 61010-1250-3, 61010-1250-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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 3 · 125 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
glycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
peppermint oilPEPPERMINT OILAV092KU4JHSOLUTION / ORAL53 mgExact identifier — unii candidate
21 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
peppermint oilPEPPERMINT OILAV092KU4JHTABLET / ORAL28 mgExact identifier — unii candidate
21 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEEPASTE / ORAL1050 mgExact identifier — unii candidate
29 equally ranked IID candidates
peppermint oilPEPPERMINT OILAV092KU4JHSHAMPOO / TOPICAL0.2 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEEPOWDER, FOR SOLUTION / ORAL10 mg/5mlExact identifier — unii candidate
29 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEETABLET / ORAL56 mgExact identifier — unii candidate
29 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESOLUTION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
peppermint oilPEPPERMINT OILAV092KU4JHELIXIR / ORAL0.04 mg/1mlExact identifier — unii candidate
21 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEETABLET, CHEWABLE, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
29 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii candidate
29 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESUSPENSION / ORAL360 mgExact identifier — unii candidate
29 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION / ORAL450 mgExact identifier — unii candidate
29 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL2350 mgExact identifier — unii candidate
29 equally ranked IID candidates
peppermint oilPEPPERMINT OILAV092KU4JHFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
peppermint oilPEPPERMINT OILAV092KU4JHPOWDER, DENTIFRICE / DENTALNAExact identifier — unii candidate
21 equally ranked IID candidates
peppermint oilPEPPERMINT OILAV092KU4JHCAPSULE / ORAL60 mgExact identifier — unii candidate
21 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEEPOWDER, FOR SUSPENSION / ORAL600 mgExact identifier — unii candidate
29 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
peppermint oilPEPPERMINT OILAV092KU4JHSPRAY, METERED / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESUSPENSION / OPHTHALMIC2 mgExact identifier — unii candidate
29 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEEPOWDER / ORAL275 mgExact identifier — unii candidate
29 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii candidate
29 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
peppermint oilPEPPERMINT OILAV092KU4JHGUM, CHEWING / ORAL526 mgExact identifier — unii candidate
21 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
peppermint oilPEPPERMINT OILAV092KU4JHFILM / BUCCAL12 mgExact identifier — unii candidate
21 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEETROCHE / ORAL948 mgExact identifier — unii candidate
29 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
peppermint oilPEPPERMINT OILAV092KU4JHSYRUP / ORAL120 mgExact identifier — unii candidate
21 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
peppermint oilPEPPERMINT OILAV092KU4JHPOWDER / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 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
587758ca-e3ab-44b3-bcce-8f45ca3f5133b6f08e1d-08bd-43cd-ae31-0c1c7491f1462019-12-09WarningsExact identifier
spl set id: b6f08e1d-08bd-43cd-ae31-0c1c7491f146

Reported adverse events (FAERS/openFDA)#

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