ROCK SAUCE  - methyl salicylate, menthol, capsicum lotion 
Shine & Pretty (USA), Corp.

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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Uses: Temporarily relives minor muscular discomfort

When using this product, do not: heat, microwave, add to hot water or any container where heating water may cause splatterring and result in burns, use in eyes or directly on mucus membrane, take by month or place in nostrils, apply to wounds or damaged skin.

Warnings: For external use only. Avoid contact with eyes. Ask a doctor before use if you have a cough associated with smoking, excessive phlegm, asthma, emphysema, persistent or chronic cough.

Directions: For the temporary relief of minor muscular discomfort. See important warnings under "When using this product". Not for use on children 5 years or younger. Apply liberally to painful area and massage until lotion is absorbed into the skin. Repeat 3-4 times daily.

Inactive Ingredients: D. I. Water, Ethylhexyl Palmitate, Cetearyl Alcohol, Glycerin, Propylene Glycol, Arnica Extract, Aloe Barbadensis (Aloe Vera) Leaf Extract, Vitamin E Acetate, Carbomer, Triethanolamine, Phenoxyethanol and Methyldibrome Glutarontrile

Keep out of the reach of children: In case of accidental ingestions, get medical help or call Poison Control Center right away.

Active Ingredient

Methyl Salicylate   20%

Menthol     10%

Capsicum   0.05%

Consult a doctor and discontinue use: If conditions persist for more than 1 week or reoccur.

MM1label

ROCK SAUCE  
methyl salicylate, menthol, capsicum lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59663-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE20 mL  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mL  in 100 mL
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM0.05 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ARNICA MONTANA (UNII: O80TY208ZW)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CARBOMER 934 (UNII: Z135WT9208)  
TROLAMINE (UNII: 9O3K93S3TK)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLDIBROMO GLUTARONITRILE (UNII: YX089CPS05)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59663-100-01120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/13/2012
Labeler - Shine & Pretty (USA), Corp. (603528605)

Revised: 6/2011
Document Id: f5cf2d9b-ccf4-4ae9-b470-b384e19e8650
Set id: 79373f11-070b-4495-b9cf-6bb94a994430
Version: 1
Effective Time: 20110602
 
Shine & Pretty (USA), Corp.