Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a90266d4-1e71-4805-aeca-6f8ed45135bb
Route
TOPICAL
Published
Effective Date 2018-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (70 mg)
Inactive Ingredients
Water Isopropyl Alcohol Glycerin Eucalyptus Oil Methyl Salicylate Peppermint Oil Coconut Oil Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-09-01

Description

USP Menthol 7%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

USP Menthol 7%

Uses

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

Warnings

For external use only.

Flammable.

Keep away from flame.

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

Water, Isopropyl Alcohol, Glycerol, Eucalyptus Leaf Oil, Wintergreen Leaf Oil, Peppermint Oil, Coconut Oil, Xanthan Gum.

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.

Principal Display Panel Pain Relief Roll On Bottle Label

NDC 61010-XXXX-X

Safetec

PAIN

RELIEF

ROLL-ON

MEDICATED FAST-ACTING

For temporary relief of

minor aches and pains

3 fl. oz. (88 ml)

Reorder no. 58001


Structured Label Content

Uses

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

Purpose

Topical Analgesic

Warnings

For external use only.

Flammable.

Keep away from flame.

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

Water, Isopropyl Alcohol, Glycerol, Eucalyptus Leaf Oil, Wintergreen Leaf Oil, Peppermint Oil, Coconut Oil, Xanthan Gum.

Keep Out of Reach of Children. (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.

Principal Display Panel Pain Relief Roll On Bottle Label (Principal Display Panel - Pain Relief Roll-On Bottle Label)

NDC 61010-XXXX-X

Safetec

PAIN

RELIEF

ROLL-ON

MEDICATED FAST-ACTING

For temporary relief of

minor aches and pains

3 fl. oz. (88 ml)

Reorder no. 58001


Advanced Ingredient Data


Raw Label Data

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