ROCKSAUCE ICE- menthol gel 
NINGBO SANTE YING MEDICALAND HEALTHDEVELOPMENT 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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rocksauce ICE

RockSauce ICE


Active Ingredient

Menthol 6.0%

Purpose

Topical Analgesic

Uses

Provides soothing cold to sore muscles

Warnings

For external use only.

Avoid contact with eyes, mucous membrane or broken skin.

When using this product:

do not: heat, microwave, add to hot water or any container where heating water may cause splattering and result in burns, use in eyes or directly on mucus membane, take by mouth or place in nostrils, apply to wounds or damaged skin.

Do not use otherwise than as directed.


Consult a doctor and discontinue use

if irritation occurs.

Keep out of reach of children.

In case of accidental ingestion, get medical help or call a Poison Control Center right away.

Directions

Apply liberally to area of pain and massage until lotion is absorbed into the skin. Repeat 3-4 times daily. See important warnings under "When using this product". Not for childern 5 years or younger. Store at 68° to 77°F (20° to 25°C).

Inactive Ingredients

Water, Isopropyl Alcohol, Glycerin, Aloe Barbadensis Leaf Extract, Calendula Officinalis Extract, Arctium Lappa (Burdock) Root Extract, Ilex Paraguariensis Leaf Extract, Arnica MOntana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis (Green Tea) Leaf Extract, Melissa Officinalis (Lemon Balm) Leaf Extract, Camphor, Isopropyl Myristate, Carbomer, Triethanolamine, Silica, Tocopheryl (Vitamin E) Acetate

RockSauce ICE

Net wt 2.5g

Icy cold pain relief cream

Soothies sore muscles and joints

DISTRIBUTED BY:

Rocktape, Inc

questions: please contact 408-912-7625

made in china

rock sauce chill

label image

ROCKSAUCE ICE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73344-101
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
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
GLYCERIN (UNII: PDC6A3C0OX)  
ARCTIUM LAPPA ROOT OIL (UNII: 55DGS3F5YG)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
MELISSA OFFICINALIS LEAF OIL (UNII: PTP6R7263M)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73344-101-012.5 g in 1 JAR; Type 0: Not a Combination Product09/29/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/29/2019
Labeler - NINGBO SANTE YING MEDICALAND HEALTHDEVELOPMENT CO.,LTD (404080257)
Registrant - NINGBO SANTE YING MEDICALAND HEALTHDEVELOPMENT CO.,LTD (404080257)
Establishment
NameAddressID/FEIBusiness Operations
NINGBO SANTE YING MEDICALAND HEALTHDEVELOPMENT CO.,LTD404080257manufacture(73344-101)

Revised: 9/2019
Document Id: 9bf85f38-706b-4086-91fb-e8af77795a06
Set id: 6d284f09-e5c6-457a-9b75-a25998dd3d8a
Version: 1
Effective Time: 20190929
 
NINGBO SANTE YING MEDICALAND HEALTHDEVELOPMENT CO.,LTD