Active Ingredients
Menthol 1.5%
Pain Relief Gel
FDA Label NDC 73672-989
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 Pain Relief Gel (NDC 73672-989). 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
Menthol 1.5%........Topical Analgesic
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
- do not bandage tightly
- do not apply to wounds or damaged skin
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
water (aqua), glycerin, peppermint (mentha piperita) leaf oil, coco-caprylate, organic hemp (cannabis sativa) aerial part extract, organic hemp (cannabis sativa) seed oil, organic aloe (aloe barbadensis) leaf juice, arnica (arnica montana) flower extract, pepper (capsicum annuum) fruit extract, ginger (zingiber officinale) root extract, organic turmeric (curcuma longa) root oil, organic rosemary (rosmarinus officinalis) leaf oil, black pepper (piper nigrum) fruit oil, clove (syzgium aromaticum) flower oil, jojoba (simmondsia chinensis) esters, lysolecithin, sclerotium gum, ethylhexylglycerin, glucose, pullulan, xanthan gum, glucose oxidase, lactoperoxidase, silica, magnesium sulfate, organic eucalyptus (eucalyptus globulus) leaf oil
Questions Or Comments?
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Package Label.Principal Display Panel
HempFusion
Pain ReliefGel
Menthol 1.5%
Including moisturizing Arnica, hemp extract with naturally occuring CBD (65mg/bottle) + Terpenes (60mg/bottle) from black pepper and clove & other natural skin moisturizers
U.S. HEMP AUTHORITY CERTIFIED
NON-GMO
ALL SKIN TYPES
50mL (1.69 fl oz)
Bottle (Hf Painrelief Gel Label V1.3 Pantone Outlined Page 001)
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