ROCKSAUCE ICE- menthol cream 
Ningbo Pulisi Daily Chemical Products Co.,Ltd.

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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rock sauce for temporary relief of muscle aches and pains

Active ingredients

Menthol    6%

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

label

ROCKSAUCE ICE 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40104-299
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.006 g  in 0.1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER 940 (UNII: 4Q93RCW27E)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:40104-299-011 in 1 PACKAGE12/05/2017
12.5 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/05/2017
Labeler - Ningbo Pulisi Daily Chemical Products Co.,Ltd. (529047265)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Pulisi Daily Chemical Products Co.,Ltd.529047265manufacture(40104-299)

Revised: 12/2017
Document Id: d8eaf690-7aef-43fb-8e87-c6b9d31c3a84
Set id: c46a6f07-79aa-40d9-9413-6c1a836a3be4
Version: 16
Effective Time: 20171213
 
Ningbo Pulisi Daily Chemical Products Co.,Ltd.