Active Ingredient
Menthol 4%
Sports Pain Relief Balm
FDA Label NDC 73672-986
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hempfusion, Inc. for the product Sports Pain Relief Balm (NDC 73672-986). 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 ingredient, 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
Menthol 4%......................Topical Analgesic
Uses
For the temporary relief of minor aches and pains of muslces 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
- do not apply to wounds or damaged skin
- do not bandage tightly
Otc - Stop Use
Stop use and ask doctor if
- condition worsens
- irritation occurs
- symptoms persist for more than 7 days or clear up and occur again within a few days
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 right away.
Directions
Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily.
Children under 12 years of age: consult a doctor.
Other Information
- Store in a cool dry place away from light
Inactive Ingredients
organic shea (butyrospermum parkii) butter, organic carnauba (copernicia cerifera) wax, peppermint (mentha piperita) leaf oil, organic sunflower (helianthus annuus) seed oil, organic jojoba (simmondsia chinensis) seed oil, organic coconut (cocos nucifera) oil, cetearyl olivate, sorbitan olivate, organic hemp (cannabis sativa) aerial part extract, organic hemp (cannabis sativa) seed oil, pepper (capsicum annuum) fruit extract, organic turmeric (cucuma longa) root oil, water (aqua), glycerin, black pepper (piper nigrum) fruit oil, clove (syzygium aromaticum) flower oil, organic rosemary (rosmarinus officinalis) leaf oil, organic eucalyptus (eucalyptus globulus) leaf oil, magnesium sulfate
Otc - Questions
Manufactured for HempFusion
3820 NW 14th Street Suite A & B
Topeka, KS 66618
877.NOW.HEMP (877.669.4367)
hempfusion.com
Principal Display Panel
Sports Pain
Relief
BALM
HempFusion
Menthol 4%
Including Capsicum, hemp extract with naturally occuring CBD (80mg/jar) + Terpenes (75mg/jar) from black pepper and clove & other natural skin moisturizers
U.S. HEMP AUTHORITY H CERTIFIED
NON-GMO
ALL SKIN TYPES
1.4 oz (40g)
Box (Hf Sportsrelief Balm Box V1.4 Page 001)
Label (Hf Sportsrelief Balm Label V1.2 Pantone Page 001)
* Please review the disclaimer below.
