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

Description

Camphor 4% Menthol 10% Methyl Salicylate 30%

Purpose

Topical analgesic Topical analgesic Topical analgesic


Medication Information

Purpose

Topical analgesic

Topical analgesic

Topical analgesic

Description

Camphor 4% Menthol 10% Methyl Salicylate 30%

Uses

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

■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Warnings

For external use only

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

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

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

Active Ingredients

Camphor 4%

Menthol 10%

Methyl Salicylate 30%

Inactive Ingredients

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

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

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

Warnings

For external use only

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

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

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

Active Ingredients (Active ingredients)

Camphor 4%

Menthol 10%

Methyl Salicylate 30%

Inactive Ingredients (Inactive ingredients)

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

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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