Universal Arthritis & Sport

SPL v2

SPL

SPL Set ID 884907a8-c884-4cce-ac10-9d4848fdba3e

Route

TOPICAL

Published

Effective Date 2023-12-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Salicylic Acid (0.61 g) Capsicum (0.0012 g)

Inactive Ingredients

Fd&c Blue No. 1 Isopropyl Alcohol Magnesium Sulfate, Unspecified Form Menthol, Unspecified Form Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-11-01

Description

Methyl Salicylate 0.61% Capsicum 0.0012%

Purpose

Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Description

Methyl Salicylate 0.61% Capsicum 0.0012%

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

COOL BLUE ICE

Formulated for:

Rubbing and Soaking

• Arthritis • Aching Stiff Joints

• Aching Muscles • Tired Aching Feet • Sprains

Extra Strength

with Rubbing Alcohol

Distributed by:

Universal Distribution Center LLC.

96 Distribution Boulevard, Edison,

NJ 08817

www.universaldc.com

Made in Jordan

Section 50565-1

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

Warnings

For external use only

Do not use • other than as directed • on children under 12 years of age

Packaging

Directions

• Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily

• Children under 12 years of age: ask a doctor

Drug Facts

Active Ingredients

Methyl Salicylate 0.61%

Capsicum 0.0012%

Inactive Ingredients

FD&C Blue No.1 (CI 42090), Isopropyl Alcohol, Magnesium Sulfate, Menthol, Water (Aqua)

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)

COOL BLUE ICE

Formulated for:

Rubbing and Soaking

• Arthritis • Aching Stiff Joints

• Aching Muscles • Tired Aching Feet • Sprains

Extra Strength

with Rubbing Alcohol

Distributed by:

Universal Distribution Center LLC.

96 Distribution Boulevard, Edison,

NJ 08817

www.universaldc.com

Made in Jordan

Section 50565-1 (50565-1)

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

Purpose

Topical Analgesic

Warnings

For external use only

Do not use • other than as directed • on children under 12 years of age

Packaging

Directions

• Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily

• Children under 12 years of age: ask a doctor

Drug Facts

Active Ingredients (Active ingredients)

Methyl Salicylate 0.61%

Capsicum 0.0012%

Inactive Ingredients (Inactive ingredients)

FD&C Blue No.1 (CI 42090), Isopropyl Alcohol, Magnesium Sulfate, Menthol, Water (Aqua)

Advanced Ingredient Data

[{"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "0.61", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CAPSICUM", "unii": "00UK7646FG", "classCode": "ACTIB", "strengthNumerator": "0.0012", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM SULFATE, UNSPECIFIED FORM", "unii": "DE08037SAB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL, UNSPECIFIED FORM", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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": "COOL BLUE ICE Formulated for: Rubbing and Soaking • Arthritis • Aching Stiff Joints • Aching Muscles • Tired Aching Feet • Sprains Extra Strength with Rubbing Alcohol Distributed by: Universal Distribution Center LLC. 96 Distribution Boulevard, Edison, NJ 08817 www.universaldc.com Made in Jordan", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Purpose": "Topical Analgesic", "Warnings": "For external use only Do not use • other than as directed • on children under 12 years of age", "Directions": "• Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily • Children under 12 years of age: ask a doctor", "Active ingredients": "Methyl Salicylate 0.61% Capsicum 0.0012%", "Inactive ingredients": "FD&C Blue No.1 (CI 42090), Isopropyl Alcohol, Magnesium Sulfate, Menthol, Water (Aqua)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:44.434069 · Updated: 2026-03-14T23:05:38.431426