Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID 815c534b-096d-49f2-b5f2-8c885d45a5e6

Route

TOPICAL

Published

Effective Date 2024-10-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Menthol, Unspecified Form (37 mg)

Inactive Ingredients

Aloe Vera Leaf Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Camphor (synthetic) .alpha.-tocopherol Acetate Ethylhexylglycerin Isopropyl Alcohol Phenoxyethanol Ilex Paraguariensis Leaf Trolamine Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-07-15

Description

SHAKE WELL

Purpose

Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Description

SHAKE WELL

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

Simple backache
Arthritis
Strains
Bruises
Sprains

Section 42229-5

SHAKE WELL

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact Poison Control Center right away.

Section 53414-9

If pregnant or breastfeeding,ask a health professional before use.

Warnings

For external use only.

Flammable:Keep away from fire or flame and heated surfaces

Do Not Use

if you are allergic to any ingredient in this product
on open wounds, damaged or irritated skin
with a heating pad or TENS device
after expiration date

Active Ingredient

Menthol 3.7%

Other Information

store in a cool place away from direct sunlight
store with cap closed tightly

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arnica Extract, Camphor, Carbomer, Ethylhexylglycerin, Ilex Paraguariensis leaf Extract, Isopropyl Alcohol, Phenoxyethanol, Tea Tree Oil, Tocopheryl Acetate (Vitamin E Acetate), Triethanolamine, Water.

When Using This Product

do not bandage tightly
do not use otherwise than as directed
avoid contact with eyes or mucous membranes

Stop Use and Ask A Doctor If

condition worsens
rash, itching, redness or excessive irritation of the skin develops
symptoms persist for more than 7 days
symptoms dear up and occur again within a few days

Adults and Children 12 Years of Age and Over:

apply to affected area no more than 4 times a day
massage painful area until absorbed into skin
wash hands after each use with cold water

Principal Display Panel 113 G Container Label

Muscle

Freeze

Relief Gel

Net Wt. 4 oz (113 g)

Principal Display Panel – 85 G Container Label

Muscle

Freeze

Relief Gel

Net Wt. 3 oz. (85 g)

Principal Display Panel – 425 G Container Label

Muscle

Freeze

Relief Gel

Net Wt. 15 oz. (425 g)

Structured Label Content

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

Simple backache
Arthritis
Strains
Bruises
Sprains

Section 42229-5 (42229-5)

SHAKE WELL

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact Poison Control Center right away.

Section 53414-9 (53414-9)

If pregnant or breastfeeding,ask a health professional before use.

Purpose

Topical Analgesic

Warnings

For external use only.

Flammable:Keep away from fire or flame and heated surfaces

Do Not Use

if you are allergic to any ingredient in this product
on open wounds, damaged or irritated skin
with a heating pad or TENS device
after expiration date

Active Ingredient (Active ingredient)

Menthol 3.7%

Other Information

store in a cool place away from direct sunlight
store with cap closed tightly

Inactive Ingredients (Inactive ingredients)

When Using This Product (When using this product)

do not bandage tightly
do not use otherwise than as directed
avoid contact with eyes or mucous membranes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition worsens
rash, itching, redness or excessive irritation of the skin develops
symptoms persist for more than 7 days
symptoms dear up and occur again within a few days

Adults and Children 12 Years of Age and Over: (Adults and children 12 years of age and over:)

apply to affected area no more than 4 times a day
massage painful area until absorbed into skin
wash hands after each use with cold water

Principal Display Panel 113 G Container Label (Principal Display Panel - 113 g Container Label)

Muscle

Freeze

Relief Gel

Net Wt. 4 oz (113 g)

Principal Display Panel – 85 G Container Label (Principal Display Panel – 85 g Container Label)

Muscle

Freeze

Relief Gel

Net Wt. 3 oz. (85 g)

Principal Display Panel – 425 G Container Label (Principal Display Panel – 425 g Container Label)

Muscle

Freeze

Relief Gel

Net Wt. 15 oz. (425 g)

Advanced Ingredient Data

[{"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLHEXYLGLYCERIN", "unii": "147D247K3P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ILEX PARAGUARIENSIS LEAF", "unii": "1Q953B4O4F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL, UNSPECIFIED FORM", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "37", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "For the temporary relief of minor aches and pains of muscles and joints associated with: Simple backache Arthritis Strains Bruises Sprains", "42229-5": "SHAKE WELL", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.", "53414-9": "If pregnant or breastfeeding, ask a health professional before use.", "Purpose": "Topical Analgesic", "Warnings": "For external use only. Flammable: Keep away from fire or flame and heated surfaces", "Do Not Use": "if you are allergic to any ingredient in this product on open wounds, damaged or irritated skin with a heating pad or TENS device after expiration date", "Active ingredient": "Menthol 3.7%", "Other Information": "store in a cool place away from direct sunlight store with cap closed tightly", "Inactive ingredients": "Aloe Barbadensis Leaf Extract, Arnica Extract, Camphor, Carbomer, Ethylhexylglycerin, Ilex Paraguariensis leaf Extract, Isopropyl Alcohol, Phenoxyethanol, Tea Tree Oil, Tocopheryl Acetate (Vitamin E Acetate), Triethanolamine, Water.", "When using this product": "do not bandage tightly do not use otherwise than as directed avoid contact with eyes or mucous membranes", "Stop use and ask a doctor if": "condition worsens rash, itching, redness or excessive irritation of the skin develops symptoms persist for more than 7 days symptoms dear up and occur again within a few days", "Adults and children 12 years of age and over:": "apply to affected area no more than 4 times a day massage painful area until absorbed into skin wash hands after each use with cold water", "Principal Display Panel - 113 g Container Label": "Muscle Freeze Relief Gel Net Wt. 4 oz (113 g)", "Principal Display Panel – 85 g Container Label": "Muscle Freeze Relief Gel Net Wt. 3 oz. (85 g)", "Principal Display Panel – 425 g Container Label": "Muscle Freeze Relief Gel Net Wt. 15 oz. (425 g)"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:44.353088 · Updated: 2026-03-14T23:03:57.888673