Pain Relief Cold Therapy Gel 3 FL OZ: Package Insert and Label Information

PAIN RELIEF COLD THERAPY GEL 3 FL OZ- menthol gel
SOTAC PHARMACEUTICAL PRIVATE LIMITED

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.

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

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 DEA Schedule

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

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE .ALPHA.-TOCOPHEROL ACETATE WATER ARCTIUM LAPPA ROOT ISOPROPYL ALCOHOL FD&C YELLOW NO. 5 CAMPHOR (NATURAL) CARBOMER 934 GLYCERIN FRANKINCENSE CALENDULA OFFICINALIS FLOWER FD&C BLUE NO. 1 ILEX PARAGUARIENSIS LEAF ISOPROPYL MYRISTATE GREEN TEA LEAF TROLAMINE ARNICA MONTANA FLOWER BRILLIANT BLUE G MELISSA OFFICINALIS LEAF ALOE VERA LEAF SORBIC ACID

Product Characteristics Color green Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72351-641-03 88.72 mL in 1 TUBE None

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	Operations
Sotac Pharmaceutical Private limited		876894019	label (72351-641), analysis (72351-641), manufacture (72351-641)

Revised: 12/2022 SOTAC PHARMACEUTICAL PRIVATE LIMITED