RUBBING DOTS NATURAL COOL PAIN RELIEF- menthol cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Available from:
Awesome Trading, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.
Authorization status:
OTC monograph not final
Authorization number:
73294-005-04, 73294-005-28

RUBBING DOTS NATURAL COOL PAIN RELIEF- menthol cream

Awesome Trading, LLC

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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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

Package Labeling: 73294-005-04

RUBBING DOTS NATURAL COOL PAIN RELIEF

menthol cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7329 4-0 0 5

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

50 mg in 1 mL

Inactive Ingredients

Awesome Trading, LLC

Inactive Ingredients

Ingredient Name

Stre ng th

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

WATER (UNII: 0 59 QF0 KO0 R)

ARNICA MO NTANA WHO LE (UNII: O8 0 TY20 8 ZW)

INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)

SHEA BUTTER (UNII: K49 155WL9 Y)

CALENDULA O FFICINALIS FLO WER (UNII: P0 M7O4Y7YD)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

GLYCERIN (UNII: PDC6 A3C0 OX)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

C13 -14 ISO PARAFFIN (UNII: E4F12ROE70 )

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

ISO STEARYL PALMITATE (UNII: 9 EHU0 R7ER1)

LAURETH-7 (UNII: Z9 5S6 G8 20 1)

DIMETHYL SULFO NE (UNII: 9 H4PO4Z4FT)

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7329 4-0 0 5-28

378 5 mL in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct

0 5/21/20 20

2

NDC:7329 4-0 0 5-0 4

110 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 5/21/20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 5/21/20 20

Labeler -

Awesome T rading, LLC (117076974)

Revised: 6/2020

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