Active Ingredients
Camphor 9.6%
Capsaicin 0.05%
Menthol 7.8%
External Analgesic Patch
FDA Label NDC 70927-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hmong 21 for the product External Analgesic (NDC 70927-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, keep out of reach of children., directions, inactive ingredients, label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
* Please review the disclaimer below.
