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

Pain Relief Cold Therapy Gel 3 FL OZ by

Drug Labeling and Warnings

Pain Relief Cold Therapy Gel 3 FL OZ by is a Otc medication manufactured, distributed, or labeled by SOTAC PHARMACEUTICAL PRIVATE LIMITED, Sotac Pharmaceutical Private limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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

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

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

Labeler - SOTAC PHARMACEUTICAL PRIVATE LIMITED (876894019)

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