ROCKSAUCE FIRE- methyl salicylate, menthol and capsaicin cream 
NINGBO SANTE YING MEDICALAND HEALTHDEVELOPMENT CO.,LTD

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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FIERY HOT PAIN RELIEF CREAM SOOTHES SORE MUSCLES AND JOINTS

Active ingredients

Methyl Salicylate 20%

Menthol USP 10%

Capsaicin 0.002%

Purpose

Topical Analgesic

Uses:

Provides soothing Cold to sore muscles and joints

Warnings:

For external use only.

Avoid contact with eyes, mucous membrane or broken skin

Keep out of reach of children.

if accidental ingestion, get medical help or call a Poison Control Center right away.

Directions:

Apply liberally to area of pain and massage unti lotion is absorbed into the skin. Repeat 3-4 times daily. Store at 68° to77°F (20°to 25°C).

When using this product

do not heat, microwave, and to hot water or any container where heating water may cause splattering and result in burns, use in eyes or directly on mucus membrans, take by mouth or place in nostrill, apply to wounds or damaged skin. Do not use otherwise than as directed

Consult a doctor and discontinus use.

if irritation occurs, ask a health professional before use if pregnant or brastfeeding. before using if you have sensitive skin.

Inactive ingredients:

Water, Aminomethyl Propanol, Aloe Barbadensis (Aloe Vera) Leaf Extract, Arnica Montana Extract, Carbomer, Cetearl Alcohol, Ethylhexylglycerin, Ethylhexyl Palmitate, Glycerin, Phenoxyethanol, Propylene Glycol, Tocopheryl Acetate

Principal Display Panel

label

ROCKSAUCE FIRE 
methyl salicylate, menthol and capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73344-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE20 mg  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 100 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.2 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ARNICA MONTANA (UNII: O80TY208ZW)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73344-103-011 in 1 PACKAGE09/29/2019
188.7 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:73344-103-021 in 1 PACKAGE09/29/2019
2355 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/29/2019
Labeler - NINGBO SANTE YING MEDICALAND HEALTHDEVELOPMENT CO.,LTD (404080257)
Establishment
NameAddressID/FEIBusiness Operations
NINGBO SANTE YING MEDICALAND HEALTHDEVELOPMENT CO.,LTD404080257manufacture(73344-103)

Revised: 9/2019
Document Id: 142191c6-01aa-4237-b731-5c0d1e6b4a28
Set id: 4f8935bb-ed83-463b-a0f3-31e65303e137
Version: 1
Effective Time: 20190929
 
NINGBO SANTE YING MEDICALAND HEALTHDEVELOPMENT CO.,LTD