ROCK SAUCE CHILL (NO COLOR)- menthol gel 
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.

----------

rock sauce chill (no color)

Rock Sauce Chill (no clolor)


Active Ingredient

Menthol 6.0%

Purpose

Cooling Pain Relief

Uses

Temporary relief from minor aches and pains of sore muscles & joints associates with

  • arthritis
  • backache
  • strains
  • sprains

Warnings

For external use only.

Flammable: keep away from excessive heat or open flame

When using this product:

  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged skin
  • do not use with other ointments, creams, sprays or liniments
  • do not apply to irritated skin or if excessive irritation develops
  • do not bandage
  • wash hands after use with cool water
  • do not use with heating pad or device

Ask a doctor before use if you have: sensitive skin

Consult a doctor and discontinue use

if conditions persist for more than 1 week or reoccur

Keep out of reach of children.

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

Directions

  • adults and children 5 years of age and older; Rub a thin film over affected areas not more than 4 times daily; massage not necessary
  • Children under 5 years of age: consult physician

Inactive Ingredients

aloe barbadensis leaf extract, arnica montana flower extract, arctium lappa root (burdock) extract, boswellia carteril resin extract, calendula officinalis extract, carbomer, cameillia sinensis (green tea) leaf extract, camphor USP, glycerin, ilex paraguariensis leaf extract, isopropyl myristate, mellssa officinalis (lemon balm) leaf extract, silicon dioxide, tocopheryl (vitamin E) acetate, triethanolamine, purified water USP, blue 1, yellow 5

Other information: store in a cool dry place; if pregnant or breast feeding, ask a health professional before use.

Topical Cooling Roll-on

Rock Sauce Chill (no color)
Net wt 8oz (3 oz/88.5 ml)

Do not eat or drink
for temporary relief of muscle aches & pains

may be used with Rocktape

DISTRIBUTED BY:

Rocktape, inc

questions: please contact 408-912-rock (7625)

made in china

rock sauce chill

label image

ROCK SAUCE CHILL (NO COLOR) 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40104-192
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER 934 (UNII: Z135WT9208)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:40104-192-0185.125 g in 1 JAR; Type 0: Not a Combination Product05/09/201503/04/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/09/201503/04/2019
Labeler - Ningbo Pulisi Daily Chemical Products Co., Ltd. (529047265)
Registrant - Ningbo Pulisi Daily Chemical Products Co., Ltd. (529047265)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Pulisi Daily Chemical Products Co., Ltd.529047265manufacture(40104-192)

Revised: 3/2019
 
Ningbo Pulisi Daily Chemical Products Co., Ltd.