Pain Relieving

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MENTHOL
Pain Relieving

Pain Relieving MENTHOL SAFETEC OF AMERICA, INC. FDA Approved Use Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis, backache, strains sprains.

Generic: MENTHOL

Mfr: SAFETEC OF AMERICA, INC. FDA OTC

Substance Menthol

Route

TOPICAL

Applications

M017

Product NDC

61010-4403-00 61010-4403-01

Package NDC

61010-4403-1

Drug Facts

Composition & Profile

Active Ingredients

Active Ingredient Menthol USP 4%

Inactive Ingredients

Inactive Ingredients Aloe Barbadensis Leaf Extract Arctium Lappa Root Extract Arnica Montana Flower Extract Boswellia Carterii Resin Extract Brilliant Blue Calendula Officinalis Extract Camellia Sinensis Leaf Extract (Green Tea Leal) Camphor Carbomer Glycerin Ilex Paraguariensis Leaf Extract Isopropyl Alcohol Isopropyl Myristate Melissa Officinalis Leaf Extract Purified Water Silicon Dioxide Tartrazine TocopheryI Acetate Triethanolamine.

Strengths

4 %

Treats Conditions

Use Temporary Relief From Minor Aches And Pains Of Sore Muscles And Joints Associated With Arthritis Backache Strains Sprains

Identifiers & Packaging

Container Type UNKNOWN

NDC 61010-4403-00

All Product Codes

61010-4403-00 61010-4403-01

UNII

L7T10EIP3A

SPL Set IDs

52ebf64d-095f-467e-bf51-dd8d33b58c7d

Packaging

Principal Display Panel – 4 oz Pain Relieving Gel Safetec ® Pain Relieving Gel For Minor Aches & Pains of Muscles & Joints Net Wt. 4 oz. (113.4g) Reorder No. 58002 Manufactured for: Safetec of America, Inc. Buffalo, NY 14215 I 1-800-456-7077 Made in India KD/739 Principal Display Panel – 4 oz Pain Relieving Gel

Package Descriptions

Principal Display Panel – 4 oz Pain Relieving Gel Safetec ® Pain Relieving Gel For Minor Aches & Pains of Muscles & Joints Net Wt. 4 oz. (113.4g) Reorder No. 58002 Manufactured for: Safetec of America, Inc. Buffalo, NY 14215 I 1-800-456-7077 Made in India KD/739 Principal Display Panel – 4 oz Pain Relieving Gel

Overview

Use Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis, backache, strains sprains.

Indications & Usage

Use Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis, backache, strains sprains.

Dosage & Administration

Directions Adults and children 2 years of age and older : Rub a thin film over affected areas not more than 4 times daily; massage not necessary Children under 2 years of age: Consult a physician

Warnings & Precautions

Warnings For external use only. Flammable: Keep away from excessive heat or open flame. Ask a doctor before use if you have: sensitive skin. When using this product: Avoid contact with eyes or mucous membranes Do not apply to wounds or damaged skin Do not use with other ointments, creams, sprays or liniments Do not apply to irritated skin or if excessive irritation develops Do not bandage Wash hands after use with cool water Do not use with heating pad or device Stop use and ask a doctor if: Condition worsens Symptoms last more than 7 days or clear up and occur again within a few days. If pregnant or breast feeding : Ask a health professional before use.

Purpose

Purpose Cooling Pain Relief

When Using

When using this product: Avoid contact with eyes or mucous membranes Do not apply to wounds or damaged skin Do not use with other ointments, creams, sprays or liniments Do not apply to irritated skin or if excessive irritation develops Do not bandage Wash hands after use with cool water Do not use with heating pad or device

Stop Use & Ask a Doctor

Stop use and ask a doctor if: Condition worsens Symptoms last more than 7 days or clear up and occur again within a few days.

Keep Out of Reach of Children

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