Avaria Pain Relief Rub

Avaria Pain Relief Rub
SPL v8
SPL
SPL Set ID b3ea7ebc-86e2-48d7-b629-8ccb2d312c6b
Route
TOPICAL
Published
Effective Date 2017-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4 g) Camphor (natural) (11 g) Salicylic Acid
Inactive Ingredients
Glycerin Sodium Hydroxide Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Cetostearyl Alcohol Ceteth-10 Phosphate Dihexadecyl Phosphate Dimethyl Sulfone Phenoxyethanol Water Arnica Montana Rice Bran Oil Isopropyl Palmitate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-10-30

Description

Camphor 4%, Menthol 4%, Methyl Salicylate 11%


Medication Information

Warnings and Precautions

Warnings

For external use only. Use only as directed.  Consult your doctor before use if you have allergies to aspirin or salicylate.  Avoid contact with eyes and mucous membranes.  If contact occurs, flush with water for 15 minutes.  Do not apply to wounds or damaged skin.  If pain persists for more than 7 days or becomes worse consult a physician.  Children under 12 years of age should consult a physician before use. 

Indications and Usage

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, back ache, strains, bruises, and sprains.

Dosage and Administration

Directions

Adults and children 12 years of age and older:  use no more than 3 to 4 times daily.  Apply cream to affected  areas and thoroughly massage until penetrated.  Wash hands with soap and water after use.

Description

Camphor 4%, Menthol 4%, Methyl Salicylate 11%

Section 50565-1

Keep out of reach of children.

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

Section 51727-6

Inactive ingredients

Arnica Montana, Carbomer, Cetearyl Alcohol, Ceteth-10 Phosphate, Dicetyl Phosphate, Glycerin, Isopropyl Palmitate, Methylsulfonylmethane (MSM), Oryza sativa (Rice) Bran Oil, Phenoxyethanol, Purified Water, Sodium Hydroxide

Section 51945-4

Section 55105-1

Purpose

Topical Analgesic.



Section 55106-9

Camphor 4%, Menthol 4%, Methyl Salicylate 11%


Structured Label Content

Indications and Usage (34067-9)

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, back ache, strains, bruises, and sprains.

Dosage and Administration (34068-7)

Directions

Adults and children 12 years of age and older:  use no more than 3 to 4 times daily.  Apply cream to affected  areas and thoroughly massage until penetrated.  Wash hands with soap and water after use.

Warnings and Precautions (34071-1)

Warnings

For external use only. Use only as directed.  Consult your doctor before use if you have allergies to aspirin or salicylate.  Avoid contact with eyes and mucous membranes.  If contact occurs, flush with water for 15 minutes.  Do not apply to wounds or damaged skin.  If pain persists for more than 7 days or becomes worse consult a physician.  Children under 12 years of age should consult a physician before use. 

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 51727-6 (51727-6)

Inactive ingredients

Arnica Montana, Carbomer, Cetearyl Alcohol, Ceteth-10 Phosphate, Dicetyl Phosphate, Glycerin, Isopropyl Palmitate, Methylsulfonylmethane (MSM), Oryza sativa (Rice) Bran Oil, Phenoxyethanol, Purified Water, Sodium Hydroxide

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Topical Analgesic.



Section 55106-9 (55106-9)

Camphor 4%, Menthol 4%, Methyl Salicylate 11%


Advanced Ingredient Data


Raw Label Data

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