Active Ingredient

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

Ask a 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 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

Stop use and ask a doctor if

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

If pregnant or breast-feeding

ask a health professional before use

Keep out of reach of Children.

If accidentally ingested, get medical help or contact a Poison Control Center (1-800-222-1222) 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

• Children under 2 years of age: consult physician

Other Information

• store in a cool dry place

Inactive ingredients

aloe vera gel, arnica montana flower extract, articum lappa root (burdock) extract, boswellia carterii resin extract, calendula officinalis extract, camellia sinensis (green tea) leaf extract, camphor, carbomer 934, colloidal silicon dioxide, FD&C blue no.1, FD&C yellow no.5, glycerin, ilex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, melissa officinalis (lemon balm) leaf extract, purified water, sorbic acid, tocopheryl acetate, triethanolamine

Questions or comments

1-856-357-7321

Pain Relief Cold Therapy Gel 3 FL OZ

Cold Therapy Gel 3 FL OZ

PAIN RELIEF COLD THERAPY GEL 3 FL OZ
menthol 4% gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72351-641
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
CARBOMER 934 (UNII: Z135WT9208)
GLYCERIN (UNII: PDC6A3C0OX)
FRANKINCENSE (UNII: R9XLF1R1WM)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TROLAMINE (UNII: 9O3K93S3TK)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
BRILLIANT BLUE G (UNII: M1ZRX790SI)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SORBIC ACID (UNII: X045WJ989B)

Product Characteristics
Color	green	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72351-641-03	88.72 mL in 1 TUBE; Type 0: Not a Combination Product	04/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/01/2021

Labeler - SOTAC PHARMACEUTICAL PRIVATE LIMITED (876894019)

Name	Address	ID/FEI	Business Operations
Establishment
Sotac Pharmaceutical Private limited		876894019	label(72351-641) , analysis(72351-641) , manufacture(72351-641)