Pain Relief Balm
FDA Label NDC 73672-988

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 Balm (NDC 73672-988). 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

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Otc - Questions

→ Principal Display Panel

Active Ingredient

Menthol 4%

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 (burtyrospermum parkii) butter, organic carnauba (copernicia cerifera) wax, peppermint leaf oil (mentha piperita), 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, black pepper (piper nigrum) fruit oil (source of terpenes), clove (syzygium aromaticum) flower oil, magnesium sulfate, rosemary (rosmarinus officinalis) extract