61010-1550-1, Pain Relieving Roll-on

Drug Facts

Composition & Product

Active Ingredients

Menthol, Unspecified Form (7 g)

Inactive Ingredients

Eucalyptus Oil Glycerin Isopropyl Alcohol Methyl Salicylate Water Tea Tree Oil Xanthan Gum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-10-07

Medication Information

Purpose

Topical Analgesic

Description

Drug Facts

Uses

Temporary relief of minor aches and pains of muscles and joints.

Section 42229-5

Drug Facts

Warnings

For external use only. Flammable.

Directions

For adults and children 2 years of age and older: Shake well and apply to affected area not more than 3-4 times daily. Will not stain clothing. For children under 2 years of age, consult a doctor.

Other Information

Store at room temperature.

Active Ingredients

USP Menthol 7%

Inactive Ingredients

Eucalyptus Oil, Glycerin, Isopropyl Alcohol, Methyl Salicylate, Purified Water, Tea Tree Oil, Xanthan Gum.

Principal Display Panel 3 Oz. Bottle Label

Safetec

PAIN RELIEVING

ROLL-ON

FAST-ACTING MUSCLE RELIEF

with Tea Tree & Eucalyptus Oils

Reorder No. 58003

3 fl. oz. (88ml) • Topical Analgesic

Keep Away From Flame. Keep Out of Reach of Children.

If swallowed get medical help or contact a poison control center right away. Avoid contact with eyes. Do not apply to open wounds or damaged skin. Do not bandage tightly.

Consult a doctor if excessive skin irritation occurs, or if you are prone to allergic reactions to salicylates, including aspirin. If condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, discontinue use of this product and consult a doctor.

Structured Label Content

Uses

Temporary relief of minor aches and pains of muscles and joints.

Section 42229-5 (42229-5)

Drug Facts

Purpose

Topical Analgesic

Warnings

For external use only. Flammable.

Directions

For adults and children 2 years of age and older: Shake well and apply to affected area not more than 3-4 times daily. Will not stain clothing. For children under 2 years of age, consult a doctor.

Other Information

Store at room temperature.

Active Ingredients

USP Menthol 7%

Inactive Ingredients

Eucalyptus Oil, Glycerin, Isopropyl Alcohol, Methyl Salicylate, Purified Water, Tea Tree Oil, Xanthan Gum.

Principal Display Panel 3 Oz. Bottle Label (Principal Display Panel - 3 oz. Bottle Label)

Safetec

PAIN RELIEVING

ROLL-ON

FAST-ACTING MUSCLE RELIEF

with Tea Tree & Eucalyptus Oils

Reorder No. 58003

3 fl. oz. (88ml) • Topical Analgesic

Keep Away From Flame. Keep Out of Reach of Children. (Keep away from flame. Keep out of reach of children.)

If swallowed get medical help or contact a poison control center right away. Avoid contact with eyes. Do not apply to open wounds or damaged skin. Do not bandage tightly.

Consult a doctor if excessive skin irritation occurs, or if you are prone to allergic reactions to salicylates, including aspirin. If condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, discontinue use of this product and consult a doctor.

Advanced Ingredient Data

[{"name": "EUCALYPTUS OIL", "unii": "2R04ONI662", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYL SALICYLATE", "unii": "LAV5U5022Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TEA TREE OIL", "unii": "VIF565UC2G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL, UNSPECIFIED FORM", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "7", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Temporary relief of minor aches and pains of muscles and joints.", "42229-5": "Drug Facts", "Purpose": "Topical Analgesic", "Warnings": "For external use only. Flammable.", "Directions": "For adults and children 2 years of age and older: Shake well and apply to affected area not more than 3-4 times daily. Will not stain clothing. For children under 2 years of age, consult a doctor.", "Other Information": "Store at room temperature.", "Active Ingredients": "USP Menthol 7%", "Inactive Ingredients": "Eucalyptus Oil, Glycerin, Isopropyl Alcohol, Methyl Salicylate, Purified Water, Tea Tree Oil, Xanthan Gum.", "Principal Display Panel - 3 oz. Bottle Label": "Safetec PAIN RELIEVING ROLL-ON FAST-ACTING MUSCLE RELIEF with Tea Tree & Eucalyptus Oils Reorder No. 58003 3 fl. oz. (88ml) • Topical Analgesic", "Keep away from flame. Keep out of reach of children.": "If swallowed get medical help or contact a poison control center right away. Avoid contact with eyes. Do not apply to open wounds or damaged skin. Do not bandage tightly. Consult a doctor if excessive skin irritation occurs, or if you are prone to allergic reactions to salicylates, including aspirin. If condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, discontinue use of this product and consult a doctor."}

61010-1550-1, Pain Relieving Roll-on

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information