ROCKSAUCE FIERY HOT PAIN RELIEF- methyl salicylate, menthol, capsaicin cream 
Implus Footcare, 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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RockSauce®
FIERY HOT PAIN RELIEF GEL
3OZ

ACTIVE INGREDIENT

Methyl Salicylate 20%

Menthol 10%

Capsaicin0.002%

PURPOSE

Topical Analgesic

USES:

Provides soothing heat to sore muscles and joints.

WARNINGS:

For external use only. Avoid contact with eyes, mucous membrane or broken skin.

When using this product, do not:

heat, microwave, add to hot water or any container where heating water may cause splattering and result in burns, use in eyes or directly on mucus membrane, take by mouth or place in nostrils, apply to wounds or damaged skin.

Do not use otherwise than as directed.

Consult a doctor and discontinue use if irritation occurs.

Ask a health professional before use if pregnant or breastfeeding.

Ask a doctor before using if you have sensitive skin.

Keep out of reach of children:

In case of accidental ingestion, get medical help or call Poison Control Center right away. Not for children 5 years or younger.

DIRECTIONS:

Apply liberally to area of pain and massage until lotion is absorbed into the skin. Repeat 3-4 times daily. Store at 68° to 77 ℉(20° to 25℃).

INACTIVE INGREDIENTS:

Aminomethyl Propanol, Aloe Barbadensis(Aloe Vera)Leaf Juice, Arnica Montana Flower Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cetearyl Alcohol, Ethylhexylglycerin, Maltodextrin, Phenoxyethanol, Propylene Glycol, Potassium Cetyl Phosphate, Tocopheryl Acetate, Water

image of bottle label

ROCKSAUCE FIERY HOT PAIN RELIEF 
methyl salicylate, menthol, capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81683-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL9.02 g  in 88.5 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0018 g  in 88.5 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE18 g  in 88.5 mL
Inactive Ingredients
Ingredient NameStrength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
WATER (UNII: 059QF0KO0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81683-013-0188.5 mL in 1 BOTTLE; Type 0: Not a Combination Product03/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/18/2021
Labeler - Implus Footcare, LLC (361531585)

Revised: 3/2021
Document Id: bdee3366-9056-0664-e053-2995a90ac4a0
Set id: bdee2b65-2759-0e62-e053-2a95a90a0378
Version: 1
Effective Time: 20210317
 
Implus Footcare, LLC