TOPCARE PAIN RELIEVING 40CT- camphor menthol methyl salicylate patch

Topcare Pain Relieving 40ct by

Drug Labeling and Warnings

Topcare Pain Relieving 40ct by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                      Purpose

Camphor 1.2%....................................................... Topical Analgesic
Menthol 5.7%......................................................... Topical Analgesic

Methyl Salicylate 6.3%............................................. Topical Analgesic

PURPOSE

Uses

For temporary relief of minor aches and pains of muscles and joints associated with:

• sprains
• simple backache
• bruises
• arthritis
• strains

WARNINGS

Warnings

For external use only

Allergy alert: If prone to allergic reaction from aspirin or slicylates, consult a doctor before use.

DO NOT USE

Do not use

• on wounds or damaged skin
• with a heating pad
• if you are allergic to any ingredients of this product
• on a child under 12 years of age with arthritis-like conditions

ASK DOCTOR

Ask a doctor before use if you have redness over the affected area.

WHEN USING

When using this product

• do not use otherwise than directed
• avoid contact with the eyes, mucous membranes or rashes
• do not badnage tightly
• discontinue use at least 1 hour before a bath or shower
• do not use immediately after a bath or shower

STOP USE

Stop use and ask a doctor if

• redness is present or irritation or rash develops
• conditions worsen symptoms persist for more than 7 days
• symptoms clear up and occur again withing a few days

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children. If swallowed, get medical help or contact a Poision Control Center (1-800-222-1222) right away.

INDICATIONS & USAGE

Directions

adults and children 12 years of age and over:

• clean and dry affected area
• remove patch from film
• apply to affected area not more than 3 to 4 times daily
• do not wear patch for more than 8 hours
• children under 12 years of age: consult a doctor

STORAGE AND HANDLING

Other information

• store at room temperature 20-25°C (68-77°F)
• avoid storing product in direct sunlight
• protect product from excessive moisture

INACTIVE INGREDIENT

butylated hydroxytoluene, glyceryl rosinate, natural rubber, polybutene, polyisobutylene, precipitated calcium carbonate, quinton, sorbitan stearate, tocopherol acetate, ys resin, zinc oxide

QUESTIONS

Questions or comments?

Call 1-888-423-0139

DOSAGE & ADMINISTRATION

DISTRIBUTED BY:Topco Associates LLC

Elk Grove Village, IL 60007

topcare@topco.com

www.topcarebrand.com

MADE IN SOUTH KOREA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOPCARE PAIN RELIEVING 40CT 
camphor menthol methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-679
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.012 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.057 mg  in 1 g
MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD) (SALICYLIC ACID - UNII:O414PZ4LPZ)	MENTHYL SALICYLATE, (+/-)-	0.063 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCERYL ROSINATE (UNII: SD112V492J)
POLYISOBUTYLENE (1100000 MW) (UNII: FLT10CH37X)
CALCIUM CARBONATE (UNII: H0G9379FGK)
ZINC OXIDE (UNII: SOI2LOH54Z)
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-679-40	40 in 1 BOX	01/09/2019
1		1 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/16/2014

Labeler - Topco Associates LLC (006935977)