RUGBY COOLING PAIN- menthol gel
Bio V Pharma Inc.

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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Rugby Cooling Pain Gel

DRUG FACTS

Active Ingredient(s)

Menthol 4%

Purpose

Cooling Pain Relief

Uses

Temporary relief from minor aches and pains of sore muscles and joints associated with: • arthritis • backache • strains • sprains

warnings

For external use only.

Flammable: Keep away from excessive heat or open flame

Consult your doctor before use if: you have sensitive skin

When using this product

Avoid contact with the eyes or mucous membranes • Do not apply to wounds or damaged skin

Do not use

• with other ointments, creams, sprays or liniments • Do not bandage • Do not apply to irritated skin or if excessive irritation develops • Do not use the heating pad or device

Stop use and ask a doctor if:

your condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur

If pregnant or breast-feeding:

Consult a health care professional before use

Keep out of reach of children:

If accidentally ingested, get medical help or contact a Poison Control Center immediately

Directions

• Adults and children 2 years of age and older:

Rub a thin film over affected areas not more than 4 times daily; massage not necessary. Wash hands after use with cool water.

• For children under 2 years of age: consult a physician

Other information

Store in a cool dry place with lid closed tightly

Inactive Ingredients

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

Questions or comments?

1-800-645-2158

Package Labeling:

Label

RUGBY COOLING PAIN
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71481-100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	40 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
FRANKINCENSE (UNII: R9XLF1R1WM)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71481-100-00	118 mL in 1 TUBE; Type 0: Not a Combination Product	06/10/2017	05/31/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	06/10/2017	05/31/2018

Labeler - Bio V Pharma Inc. (202672721)

Revised: 2/2019

Document Id: 82447b4e-cd11-60fc-e053-2991aa0acdc6

Set id: 3724041c-c891-4a80-803e-e89691088112

Version: 4

Effective Time: 20190219

Bio V Pharma Inc.