61010-8201. Pain Relief Spray

61010-8201. Pain Relief Spray
SPL v2
SPL
SPL Set ID 79e3b0e7-4ba5-4b9d-a980-5b6f18dba802
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG 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.

Section 50569-3

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.

Section 50570-1

Do not apply to open wounds or damaged skin. Do not bandage tightly.

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.

Keep Out of Reach of Children.

If swallowed get medical help or contact a poison control center right away. Avoid contact with eyes.

Principal Display Panel Pain Relief Spray Bottle Label

NDC 61010-XXXX-X

Safetec

PAIN

RELIEF

SPRAY

MEDICATED FAST-ACTING

For temporary relief of minor aches and pains

2 fl. oz. (59.1 ml)


Structured Label Content

Uses

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

Section 50569-3 (50569-3)

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.

Section 50570-1 (50570-1)

Do not apply to open wounds or damaged skin. Do not bandage tightly.

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.

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.

Principal Display Panel Pain Relief Spray Bottle Label (Principal Display Panel - Pain Relief Spray Bottle Label)

NDC 61010-XXXX-X

Safetec

PAIN

RELIEF

SPRAY

MEDICATED FAST-ACTING

For temporary relief of minor aches and pains

2 fl. oz. (59.1 ml)


Advanced Ingredient Data


Raw Label Data

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