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ROCK SAUCE by Shine & Pretty (USA), Corp.

Medically reviewed on June 4, 2018

Dosage form: lotion
Ingredients: METHYL SALICYLATE 20mL in 100mL, MENTHOL 10mL in 100mL, CAPSICUM 0.05mL in 100mL
Labeler: Shine & Pretty (USA), Corp.
NDC Code: 59663-100

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.

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.

MM1

ROCK SAUCE  
methyl salicylate, menthol, capsicum lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59663-100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE20 mL  in 100 mL
MENTHOL (MENTHOL) MENTHOL10 mL  in 100 mL
CAPSICUM (CAPSICUM) CAPSICUM0.05 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ETHYLHEXYL PALMITATE 
CETOSTEARYL ALCOHOL 
GLYCERIN 
PROPYLENE GLYCOL 
ARNICA MONTANA 
ALOE VERA LEAF 
ALPHA-TOCOPHEROL ACETATE 
CARBOMER 934 
TROLAMINE 
PHENOXYETHANOL 
METHYLDIBROMO GLUTARONITRILE 
Packaging
#Item CodePackage Description
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)

 
Shine & Pretty (USA), Corp.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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