Active Ingredients
Camphor USP 11%, Menthol USP 16%
Active Recovery Pain Relief Ointment
FDA Label NDC 79845-768
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Charlotte's Web, Inc. for the product Active Recovery Pain Relief (NDC 79845-768). 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, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Camphor USP 11%, Menthol USP 16%......................External Analgesics
Uses
For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises & sprains.
Warnings
For external use only
Otc - When Using
When using this product
- avoid contact with eyes, nostrils and mouth
- do not apply to wounds or damaged skin
- do not bandage tightly.
Otc - Stop Use
Stop use and ask a doctor if
- condition worsens
- symptoms persist for more than 7 days
- symptomsclear up and occur again within a few days
- excessive skin irritation develops.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding,ask a health professional before use
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
- adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
- children under 2 years of age: consult a physician.
- wash hands after use with cool water.
Other Information
- store at 20-25°C (68-77°F)
- store in a cool dry place away from direct sunlight
Inactive Ingredients
Beeswax, Cottonseed Oil, Clove Oil, Eucalyptus Oil, Jojoba Seed Oil, Peppermint Oil, Tea Tree Oil
Questions Or Comments?
Call 1-855-790-8169
Package Label.Principal Display Panel
Charlotte's Web
Active Recovery
Muscle & Joint Pain Relief Ointment
Cooling Essential Oils
Camphor 11% | Menthol 16%
NET WT. 1.55 OZ (44 G)
* Please review the disclaimer below.
