Relieve And Relax Pain Relieving

Relieve And Relax Pain Relieving
SPL v8
SPL
SPL Set ID c0528c36-d322-8110-e053-2995a90add6c
Route
TOPICAL
Published
Effective Date 2021-04-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (40 mg) Menthol (100 mg)
Inactive Ingredients
Caprylyl Glycol Eucalyptus Oil Glucosamine Sulfate Glycerin Magnesium Chloride Peppermint Oil Phenoxyethanol Propylene Glycol Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-06-01

Description

Camphor 4.0% w/w Menthol 10.0% w/w

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Camphor 4.0% w/w Menthol 10.0% w/w

Uses:

Temporarily relieves the minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings:

• For external use only.

• Flammable, Keep away from fire or flame.

• Avoid getting into eyes or on mucous membranes.

• If conditions worsens, or if symptoms persist for more than 7 days or clear up and occur within a few days, discontinue use of this product and consult a doctor.

Do Not Use

• on wounds or damaged skin.

• Do not bandage tightly. • Caution: Discontinue use if excessive irritation of the skin develops.

Directions:

SHAKE WELL BEFORE USE Adults and children 12 years of age and older: Using the roll-on applicator, massage a liberal amount of gel directly on the affected area not more than 3-4 times daily. Children under 12 years of age: Ask a doctor.

Package Labeling:

Active Ingredients

Camphor 4.0% w/w

Menthol 10.0% w/w

Other Information:

Store between 10 and 30ºC (50-86ºF) Avoid freezing and excessive heat above 32ºC (90ºF)

Inactive Ingredients:

Acrylates/Beheneth- 25 Methacrylate Copolymer,Caprylyl Glycol, Chondroitin Sulfate, Ethanol SDA 40B, Eucalyptus Oil, Glucosamine Sulfate, Glycerin, Magnesium Chloride, Peppermint Oil, Phenoxyethanol, Propylene Glycol, Triethanolamine, Water

Questions Or Comments?

Call Toll Free: 954-747-3300 Monday through Friday 8:30 AM to 5:00 PM EST. Visit us: www.RelieveAndRelax.com email us: [email protected] Or Write us: MAC Innovations, LLC Attn: Quality Assurance Dept. 2301 SW 145th Ave. Miramar, FL USA 33027













Keep Out of Reach of Children.

• Use only as directed. • Do not use if pregnant or breastfeeding. • If swallowed, get medical help or contact a poison control center right away.




Structured Label Content

Uses:

Temporarily relieves the minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Purpose

Topical Analgesic

Warnings:

• For external use only.

• Flammable, Keep away from fire or flame.

• Avoid getting into eyes or on mucous membranes.

• If conditions worsens, or if symptoms persist for more than 7 days or clear up and occur within a few days, discontinue use of this product and consult a doctor.

Do Not Use (Do not use)

• on wounds or damaged skin.

• Do not bandage tightly. • Caution: Discontinue use if excessive irritation of the skin develops.

Directions:

SHAKE WELL BEFORE USE Adults and children 12 years of age and older: Using the roll-on applicator, massage a liberal amount of gel directly on the affected area not more than 3-4 times daily. Children under 12 years of age: Ask a doctor.

Package Labeling:

Active Ingredients

Camphor 4.0% w/w

Menthol 10.0% w/w

Other Information:

Store between 10 and 30ºC (50-86ºF) Avoid freezing and excessive heat above 32ºC (90ºF)

Inactive Ingredients:

Acrylates/Beheneth- 25 Methacrylate Copolymer,Caprylyl Glycol, Chondroitin Sulfate, Ethanol SDA 40B, Eucalyptus Oil, Glucosamine Sulfate, Glycerin, Magnesium Chloride, Peppermint Oil, Phenoxyethanol, Propylene Glycol, Triethanolamine, Water

Questions Or Comments? (Questions or Comments?)

Call Toll Free: 954-747-3300 Monday through Friday 8:30 AM to 5:00 PM EST. Visit us: www.RelieveAndRelax.com email us: [email protected] Or Write us: MAC Innovations, LLC Attn: Quality Assurance Dept. 2301 SW 145th Ave. Miramar, FL USA 33027













Keep Out of Reach of Children. (Keep out of reach of children.)

• Use only as directed. • Do not use if pregnant or breastfeeding. • If swallowed, get medical help or contact a poison control center right away.




Advanced Ingredient Data


Raw Label Data

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