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rock sauce by Ningbo Pulisi Daily Chemical Products Co.,Ltd.

Medically reviewed on December 29, 2016

Dosage form: lotion
Ingredients: METHYL SALICYLATE 20mg in 100mL, MENTHOL 10mg in 100mL, CAPSAICIN 0.2mg in 100mL
Labeler: Ningbo Pulisi Daily Chemical Products Co.,Ltd.
NDC Code: 40104-196

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.

rock sauce for temporary relief of muscle aches and pains

Active ingredients

Methyl Salicylate 20%

Menthol USP 10%

Capsaicin 0.002%

Purpose

Topical Analgesic

Uses:

For temporary relief minor muscular discomfort

Warnings:

For external use only.

Avoid contact with eyes, mucous membrane or broken skin

Keep out of reach of children.

if accidentally ingested, getmedical help or contact a Poison Control Center immediately.

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. Store at 68 to 77F (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 conditions persist for more than 1 week or reocur.

Inactive ingredients:

Water, benzocaine, glyceryl stearate, PEG 100 stearate, stearic acid, propylene glycol, cetyl alcohol, dimethyl sulfoxide, poloxamer 407, capsaicin, aloe barbadensis gel, borage oil, ammonium acryloyldimethyltaurate, zingiber officinale root extract, boswelia serrata extract, soya lecithin, methylparaben, propylparaben, DMDM hydantoin, sodium stearoyl glutamate, triethanolamine.

Principal Display Panel

ROCK SAUCE 
methyl salicylate, menthol and capsaicin lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40104-196
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE20 mg  in 100 mL
MENTHOL (MENTHOL) MENTHOL10 mg  in 100 mL
CAPSAICIN (CAPSAICIN) CAPSAICIN0.2 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER 940 
ISOPROPYL ALCOHOL 
ISOPROPYL MYRISTATE 
SILICON DIOXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:40104-196-011 BOTTLE in 1 PACKAGE
1946 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/29/2016
Labeler - Ningbo Pulisi Daily Chemical Products Co.,Ltd. (529047265)
Establishment
NameAddressID/FEIOperations
Ningbo Pulisi Daily Chemical Products Co.,Ltd.529047265manufacture(40104-196)

 
Ningbo Pulisi Daily Chemical Products Co.,Ltd.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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