FDA Label for External Analgesic

View Indications, Usage & Precautions

External Analgesic Product Label

The following document was submitted to the FDA by the labeler of this product Hmong 21. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients



Camphor 9.6%

Capsaicin 0.05%

Menthol 7.8%


Purpose



External Analgesic


Uses



For the temporary relief of minor aches and pains of muscles and joints associated with

-simple backache

-arthritis

-strains

-bruises

-sprains


Warnings



When using this product

-avoid contact with the eyes

- do not apply to wounds or damaged skin

-do not bandage tightly

Stop use and ask a doctor if

- condition worsens

-if synthoms oersust for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding, ask a health professional before use.


Keep Out Of Reach Of Children.



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


Directions



Adults and children 12 years of age and older:

-Clean and dry affected area.

-Remove from backing film and apply.

-Remove from the skin after at most 8 hours' application.

-Apply to the affected area not more than 3 times daily.

-Children under 12 years of age: Consult a doctor.


Inactive Ingredients



Acrylic Acid, Aluminum Hydroxide, Carmellose Sodium, 2-ethylhexylacrylate, Glycerin, Methyl Acrylate, Polyacrylate, polyacrylic Acid, sodium polyacrylatem, Tartaric Acid, Water.


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