Active Ingredients
Capsaicin .025%
Roll Pain Away Lavender Gel
FDA Label NDC 72683-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Proximity Capital Partners Llc Dba Asutra for the product Roll Pain Away Lavender (NDC 72683-010). 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
Capsaicin .025%..................Topical Analgesic
Uses
Temporarily relieves minor aches and pains of muscles and joints associated with:
- arthritis
- simple backache
- strains
- sprains
- bruises
Warnings
Use only as directed.
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
- symptoms persist for more than 7 days, or clear up and reoccur again within a few days
- redness is present
- irritation develops
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If accidentally ingested, get medical help or contact Poison Control Center immediately.
Directions
Adults and children over 18 years:
- Apply to affected area. Massage into the painful area until thoroughly absorbed. Repeat as necessary but no more than 3 to 4 times daily.
- Wash hands with soap and water after applying
- Consult a doctor.
Children 18 years and younger:
Other Information
- Store in a cool, dry place
- Keep away from excessive heat or flame
- Tamper-evident for your protection. Use only if safety seal is intact.
Inactive Ingredients
Purified Water, Magnesium Chloride, C15-19 Alkane, Cetearyl Alcohol, Caprylic/Capric Triglycerides, Methylsulfonylmethane, Glycerin USP, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Co-polymer, Benzyl Alchol & Salicylic Acid & Glycerin & Sorbic Acid, Lavandula Angustifolia (Lavender) Oil, Tocopheryl Acetate
Questions Or Comments?
888-819-6472; Monday-Friday, 9am-5pm CT; Report any serious side effects to number above
Package Label.Principal Display Panel
NDC: 72683-010-01
Asutra*
Roll pain away
.025% Capsaicin
Pain RElief Gel
With Revitalizing Magnesium and Lavender
Paraben Free
Non-Toxic
Animal Test-Free and Vegan
3.4 oz | 96g
* Please review the disclaimer below.
