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

Cold Therapy Gel 3 FL OZ
(click image for full-size original)

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

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