ROCK SAUCE- methyl salicylate, menthol, capsicum lotion

ROCK SAUCE by

Drug Labeling and Warnings

ROCK SAUCE by is a Otc medication manufactured, distributed, or labeled by Shine & Pretty (USA), Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Uses: Temporarily relives minor muscular discomfort

INDICATIONS & USAGE

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

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

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 REACH OF CHILDREN

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

ACTIVE INGREDIENT

Active Ingredient

Methyl Salicylate   20%

Menthol     10%

Capsicum   0.05%

INFORMATION FOR PATIENTS

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

PRINCIPAL DISPLAY PANEL

MM1

INGREDIENTS AND APPEARANCE

ROCK SAUCE  
methyl salicylate, menthol, capsicum lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59663-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y)	METHYL SALICYLATE	20 mL  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mL  in 100 mL
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG)	CAPSICUM	0.05 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59663-100-01	120 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/13/2012

Labeler - Shine & Pretty (USA), Corp. (603528605)