PAIN RESCUE- menthol cream 
SONORAN NUTRA LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Pain RESCUE

Purpose

Topical Analgesic

Warnings

Warnings: For external use only. Avoid contact with eyes, wounds, broken
skin or mucous membranes. Do not bandage tightly or use with heating pad.

Uses

Uses temporary relief of minor aches, muscles and joint pain associate with:
•Arthritis • Fibromyalgia • Back, Neck, Shoulder, Leg, Hand and Foot Pain •
Sports Injuries • Stiffness • Sprains • Sciatica

Keep out of reach of children.

 If swallowed, seek medical help or contact Poison Control Center immediately. Children under 12 years of age, consult a
doctor. If pregnant or breastfeeding consult healthcare professional before use.

Directions

Apply liberally to the affected area, massage until well absorbed.

Use 3-4 times daily for a minimum initial period of 7-10 days for acute pain.

Use 2 times daily or as needed for chronic pain.

Let cream dry after application to prevent staining.

This product may cause an allergic reaction on some individuals.

Test on a small area before use. Store at room temperature.

Stop use

Stop Use if irritation occurs, condition worsens or lasts more than 7 days

Active ingredient

Menthol

Inactive Ingredient

Ingredients: Aloe Barbadensis (Aloe Vera Leaf Extract), Arnica
Montana Flower Extract, Boswellia Serrata (Frankincense) Oil, Capsaicin,
Dicaprylate/Caprylic Acids, Glucosamine, Helianthus Annuus (Sunflower) Seed
Oil, Hemp Seed Oil, Methylsulfonylmethane (MSM), Phenoxyethanol,
Rosmarinus Officinalis (Rosemary) Oil, Tridecth 6, Turmeric, Water (Aqua)

Pckage carton

image description

PAIN RESCUE 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72648-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
CAPSAICIN (UNII: S07O44R1ZM)  
CAPRYLIC ACID (UNII: OBL58JN025)  
GLUCOSAMINE (UNII: N08U5BOQ1K)  
SUNFLOWER SEED OIL GLYCERETH-8 ESTERS (UNII: 358X17CAT0)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
TURMERIC (UNII: 856YO1Z64F)  
WATER (UNII: 059QF0KO0R)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72648-100-0160 g in 1 TUBE; Type 0: Not a Combination Product11/06/201801/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/06/201801/30/2021
Labeler - SONORAN NUTRA LLC (080658393)
Establishment
NameAddressID/FEIBusiness Operations
SONORAN NUTRA LLC080658393manufacture(72648-100)

Revised: 7/2021
 
SONORAN NUTRA LLC