muscle and joint pain relieve

muscle and joint pain relieve
SPL v1
SPL
SPL Set ID b6e1dc50-6974-3dc8-e053-2995a90aa8ea
Route
topical
Published
Effective Date 2015-02-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
camphor (natural) (4 g) menthol (10 g) salicylic acid (30 g)
Inactive Ingredients
carbomer homopolymer type c (allyl pentaerythritol crosslinked) edetate disodium glyceryl stearate se lanolin polysorbate 80 potassium hydroxide stearic acid trolamine water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2015-01-31

Purpose

Topical analgesic Topical analgesic Topical analgesic

Description

Camphor 4% Menthol 10% Methyl Salicylate 30%


Medication Information

Warnings

For external use only

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with :

■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Purpose

Topical analgesic

Topical analgesic

Topical analgesic

Directions

■ use only as directed ■ adults and children 12 years of age and older: apply to affected area not more than 3 to 4 time daily

■ children under 12 years of age: ask a doctor

Other Information

■ store between 20 to 25C (68 to 77F) ■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

Inactive Ingredients

carbomer 940, edetate disodium, glyceryl stearate se, lanolin, polysorbate 80, potassium hydroxide, purified water, stearic acid, trolamine

Description

Camphor 4% Menthol 10% Methyl Salicylate 30%

Do Not Use

■ on wounds or damaged skin ■ with a heating pad

■ on a child under 12 years of age with arthritis like conditions

Package Label

Active Ingredients

Camphor 4%

Menthol 10%

Methyl Salicylate 30%

When Using This Product

■ avoid contact with eyes or mucous membranes ■ do not bandage tightly

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 occurs

Keep Out of Reach of Children

to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately.


Structured Label Content

Warnings

For external use only

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with :

■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Purpose

Topical analgesic

Topical analgesic

Topical analgesic

Directions

■ use only as directed ■ adults and children 12 years of age and older: apply to affected area not more than 3 to 4 time daily

■ children under 12 years of age: ask a doctor

Other Information (Other information)

■ store between 20 to 25C (68 to 77F) ■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

Inactive Ingredients (Inactive ingredients)

carbomer 940, edetate disodium, glyceryl stearate se, lanolin, polysorbate 80, potassium hydroxide, purified water, stearic acid, trolamine

Do Not Use (Do not use)

■ on wounds or damaged skin ■ with a heating pad

■ on a child under 12 years of age with arthritis like conditions

Package Label

Active Ingredients (Active ingredients)

Camphor 4%

Menthol 10%

Methyl Salicylate 30%

When Using This Product (When using this product)

■ avoid contact with eyes or mucous membranes ■ do not bandage tightly

Stop Use and Ask A Doctor If (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 occurs

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

to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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