RUBBING DOTS NATURAL COOL PAIN RELIEF- menthol cream 
Awesome Trading, LLC

----------

RUBBING DOTS Pain Relieving Cream

DRUG FACTS:

Active Ingredient:

Menthol 5.00%

Topical Analgesic

Indications:

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.

Warnings:

For external use only. Avoid contact with eyes. If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children.

If swallowed, consult physician.

Do not apply to wounds or damaged skin.

Do not bandage tightly.

If pregnant or breast feeding, contact physician prior to use.

Directions:

Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.

Children under two-years of age: consult a physician.

Additional Information:

Store at room temperature.

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Extract, Boswellia Serrata Extract, *Butyrospermum Parkii (Shea) Butter, *Calendula Officinalis Extract, Cetearyl Alcohol, Ethylhexylglycerin, *Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isopropyl Alcohol, Isostearyl Palmitate, Laureth-7, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid.

Package Labeling: 73294-005-28

Label

Package Labeling: 73294-005-04

Label1

Tube

RUBBING DOTS NATURAL COOL PAIN RELIEF 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73294-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA WHOLE (UNII: O80TY208ZW)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
SHEA BUTTER (UNII: K49155WL9Y)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)  
LAURETH-7 (UNII: Z95S6G8201)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73294-005-283785 mL in 1 JAR; Type 0: Not a Combination Product05/21/2020
2NDC:73294-005-04110 mL in 1 TUBE; Type 0: Not a Combination Product05/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01705/21/2020
Labeler - Awesome Trading, LLC (117076974)

Revised: 11/2023
Document Id: 09dc4870-a286-48af-e063-6394a90aa79e
Set id: 137a88ff-e409-4a67-addc-883194c356ae
Version: 5
Effective Time: 20231111
 
Awesome Trading, LLC