EXTERNAL ANALGESIC
EXTERNAL ANALGESIC is an FDA drug label for the active ingredient CAMPHOR, CAPSICUM, MENTHOL manufactured by Hmong 21 administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231226.
- Generic name
- CAMPHOR, CAPSICUM, MENTHOL
- Manufacturer
- Hmong 21
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 70927-001
- Application
- M017
- Label effective
- 20231226
About this product
EXTERNAL ANALGESIC is an FDA-registered drug product whose active ingredient is CAMPHOR, CAPSICUM, MENTHOL. It is labelled by Hmong 21 taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 70927-001, application M017, label effective 20231226. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing CAMPHOR, CAPSICUM, MENTHOL are most often described in connection with: temporary relief, minor aches, pains muscles, joints associated, simple backache, arthritis strains, bruises sprains. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses For the temporary relief of minor aches and pains of muscles and joints associated with -simple backache -arthritis -strains -bruises -sprains
Dosage & Administration
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.
Warnings
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.
Recall and safety notices
5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0165-2026 | DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08 | DermaRite Industries, LLC | Class II | Ongoing | 20251126 |
| D-0611-2025 | DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08 | DermaRite Industries, LLC | Class I | Ongoing | 20250910 |
| D-0426-2025 | KOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl salicylate 10.5% - External Analgesic), 2 oz (60 g) Jar, Distributed by: Pharmadel LLC, New Castle, DE 19720, NDC 55758-109-02, UPC 8 99711 00101 3. | KENIL HEALTHCARE PRIVATE LIMITED | Class II | Terminated | 20250528 |
| D-0427-2025 | Optim V, Anti-Itch Cream, Benzocaine 20% & Resorcinol 3% - External analgesic, Net Wt. Peso Neto 1 oz (28g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-300-01, UPC 8 59424 00420 6. | KENIL HEALTHCARE PRIVATE LIMITED | Class II | Terminated | 20250528 |
| D-1147-2023 | Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NET WT. 2.1 OZ. (60g) NDC 50268-195-60, Manufactured for: AvKARE, Pulaski, TN 38478 | AVKARE LLC | Class II | Terminated | 20230913 |
Frequently asked questions
What is EXTERNAL ANALGESIC used for?
Uses For the temporary relief of minor aches and pains of muscles and joints associated with -simple backache -arthritis -strains -bruises -sprains
Who makes EXTERNAL ANALGESIC?
Hmong 21 is the labeler of record for EXTERNAL ANALGESIC.
What form does EXTERNAL ANALGESIC come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is EXTERNAL ANALGESIC prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Has EXTERNAL ANALGESIC been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.