61010-8200, pain spray

61010-8200, pain spray
SPL v2
SPL
SPL Set ID b0f4010c-995f-40e1-aa40-92760e697a61
Route
topical
Published
Effective Date 2011-10-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol, unspecified form (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 2011-10-26

Purpose

Topical Analgesic

Description

Pain Spray Drug Facts


Medication Information

Purpose

Topical Analgesic

Description

Pain Spray Drug Facts

Principal Display Panel

NDC 61010-8200-1

Safetec

First Aid

Pain Spray

For Temporary

Pain Relief of

Minor Aches

And Pains

4 fl. oz. (118 ml)

Uses:

For the temporary relief of minor aches and pains of muscles and joints.

Section 42229-5

Pain Spray

Drug Facts

Section 50565-1
  • Keep out of reach of children-if swallowed get medical help or contact a poison 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.
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.

Active Ingredients

USP Menthol 7%

Other Information:

Store at room temperature.

Inactive Ingredients:

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

Manufactured by

SAFETEC OF AMERICA, Inc. Buffalo, NY 14215

800-456-7077 www.safetec.com


Structured Label Content

Purpose

Topical Analgesic

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 61010-8200-1

Safetec

First Aid

Pain Spray

For Temporary

Pain Relief of

Minor Aches

And Pains

4 fl. oz. (118 ml)

Uses:

For the temporary relief of minor aches and pains of muscles and joints.

Section 42229-5 (42229-5)

Pain Spray

Drug Facts

Section 50565-1 (50565-1)
  • Keep out of reach of children-if swallowed get medical help or contact a poison 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.
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.

Active Ingredients

USP Menthol 7%

Other Information:

Store at room temperature.

Inactive Ingredients:

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

Manufactured by

SAFETEC OF AMERICA, Inc. Buffalo, NY 14215

800-456-7077 www.safetec.com


Advanced Ingredient Data


Raw Label Data

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