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rocksauce ice by Ningbo Pulisi Daily Chemical Products Co.,Ltd.

Dosage form: cream
Ingredients: METHYL SALICYLATE 0.02g in 0.1g, MENTHOL 0.01g in 0.1g, CAPSAICIN 0.000002g in 0.1g
Labeler: Ningbo Pulisi Daily Chemical Products Co.,Ltd.
NDC Code: 40104-199

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:

2-amino-2-methyl-1-propanol, Aloe barbadensis (aloe vera) Leaf Extract, Arnica Montana Extract, Carbomer, Cetearyl Alcohol, Ethylhexylglycerin, Ethylhexyl, Palmitate, Glycerin, Methylisothiazolinone, Propylene Glycol, Tocopheryl Acetate, Water

Principal Display Panel

ROCKSAUCE ICE 
methyl salicylate, menthol and capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40104-199
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE0.02 g  in 0.1 g
MENTHOL (MENTHOL) MENTHOL0.01 g  in 0.1 g
CAPSAICIN (CAPSAICIN) CAPSAICIN0.000002 g  in 0.1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER 940 
ISOPROPYL ALCOHOL 
ISOPROPYL MYRISTATE 
SILICON DIOXIDE 
GLYCERIN 
ETHYLHEXYLGLYCERIN 
PROPYLENE GLYCOL 
METHYLISOTHIAZOLINONE 
WATER 
Packaging
#Item CodePackage Description
1NDC:40104-199-011 BOTTLE in 1 PACKAGE
12.5 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/27/2017
Labeler - Ningbo Pulisi Daily Chemical Products Co.,Ltd. (529047265)
Establishment
NameAddressID/FEIOperations
Ningbo Pulisi Daily Chemical Products Co.,Ltd.529047265manufacture(40104-199)

Revised: 09/2017
 
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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