Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 132af5e7-e6fc-4d25-98bd-79d2d8b61b6d
Route
TOPICAL
Published
Effective Date 2017-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (16 g) Camphor (synthetic) (11 g)
Inactive Ingredients
Clove Oil Corymbia Citriodora Leaf Oil Cottonseed Oil Jojoba Oil Magnesium Oxide Peppermint Oil Silver Oxide Sorbic Acid Tea Tree Oil White Wax Zinc Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-06-01

Description

Menthol 16%, Camphor 11%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 16%, Camphor 11%

Uses

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

Warnings

For external use only. Do not use on wounds or damaged skin. When using this product - avoid contact with eyes or mucous membranes - do not bandage tightly or use with heating pad. Stop use and ask a doctor if - condition worsens or symptoms persist for more than 7 days - symptoms clear up and occur again within a few days - excessive skin irritation develops.

Directions

Adults and children 12 years and older: Massage ointment into affected area not more than 3 to 4 times daily. Children under 12 years of age: Ask a doctor.

Active Ingredients

Menthol 16%, Camphor 11%

Inactive Ingredients

Beeswax, Clove Oil, Cottonseed Oil, Eucalyptus Citriodora Oil, Jojoba Seed Oil, Magnesium Oxide, Peppermint Oil, Silver Oxide, Sorbic Acid, Tea Tree Oil, Zinc Oxide

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Principal Display Panel 50g Tube

Fastrin

Aches & Pain

Deep Relief Ointment

Net WT 50g (1.76 oz.)


Structured Label Content

Uses

Temporarily relieves 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. Do not use on wounds or damaged skin. When using this product - avoid contact with eyes or mucous membranes - do not bandage tightly or use with heating pad. Stop use and ask a doctor if - condition worsens or symptoms persist for more than 7 days - symptoms clear up and occur again within a few days - excessive skin irritation develops.

Directions

Adults and children 12 years and older: Massage ointment into affected area not more than 3 to 4 times daily. Children under 12 years of age: Ask a doctor.

Active Ingredients

Menthol 16%, Camphor 11%

Inactive Ingredients

Beeswax, Clove Oil, Cottonseed Oil, Eucalyptus Citriodora Oil, Jojoba Seed Oil, Magnesium Oxide, Peppermint Oil, Silver Oxide, Sorbic Acid, Tea Tree Oil, Zinc Oxide

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

If swallowed, get medical help or contact a Poison Control Center immediately.

Principal Display Panel 50g Tube (PRINCIPAL DISPLAY PANEL - 50g Tube)

Fastrin

Aches & Pain

Deep Relief Ointment

Net WT 50g (1.76 oz.)


Advanced Ingredient Data


Raw Label Data

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