61010-4403-1

61010-4403-1
SPL v2
SPL
SPL Set ID 52ebf64d-095f-467e-bf51-dd8d33b58c7d
Route
TOPICAL
Published
Effective Date 2019-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4 g)
Inactive Ingredients
Aloe Vera Leaf Arctium Lappa Root Arnica Montana Frankincense Fd&c Blue No. 1 Calendula Officinalis Flower Green Tea Leaf Camphor (natural) Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Glycerin Ilex Paraguariensis Leaf Isopropyl Alcohol Melissa Officinalis Leaf Water Silicon Dioxide Fd&c Yellow No. 5 .alpha.-tocopherol Acetate Triethylamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-11-01

Description

Drug Facts

Purpose

Cooling Pain Relief


Medication Information

Purpose

Cooling Pain Relief

Description

Drug Facts

Use

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

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50569-3

Ask a doctor before use if you have:sensitive skin.

Section 51945-4

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 IndiaKD/739

Section 53414-9

If pregnant or breast feeding: Ask a health professional before use.

Warnings
  • For external use only.

Flammable:Keep away from excessive heat or open flame.

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
Active Ingredient

Menthol USP 4%

Other Information

Store in a cool dry place.

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.

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.

Structured Label Content

Use

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have:sensitive skin.

Section 51945-4 (51945-4)

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 IndiaKD/739

Section 53414-9 (53414-9)

If pregnant or breast feeding: Ask a health professional before use.

Purpose

Cooling Pain Relief

Warnings
  • For external use only.

Flammable:Keep away from excessive heat or open flame.

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
Active Ingredient

Menthol USP 4%

Other Information

Store in a cool dry place.

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.

When Using This Product: (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: (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.

Advanced Ingredient Data


Raw Label Data

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