LEADER MEDICATED RELIEF PATCH (camphor- synthetic levomenthol salicylic acid patch

Leader Medicated Relief Patch by

Drug Labeling and Warnings

Leader Medicated Relief Patch by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH, INC, Foshan Aqua Gel Biotech Co., Ltd.,. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Active Ingredient: Purpose
• DL-Camphor 1.2%: Topical Analgesic
• L-Menthol 5.7%: Topical Analgesic
• Methyl Salicylate 6.3%: Topical Analgesic

INACTIVE INGREDIENT

Glyceryl Hydrogenated Rosinate, Styrene/Isoprene Copolymer, Hydrated Silica, Mineral Oil, Polyisobutylene (1300 MW), PEG-400, Zinc Oxide, Ys Resin.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Temporary relief of aches and pains associated with arthritis, simple backache, strains, sprains, bruises.

WARNINGS

For External Use Only

DOSAGE & ADMINISTRATION

Adults and children over 12 years: clean and dry affected area. Carefully remove backing from patch. Apply sticky side of patch to affected area.

Wear one patch up to 8 hours. Repeat as necessary, no more than 4 times daily, no more than 7 consecutive days.

Children 12 years or younger, consult a physician.

PURPOSE

Topical Analgesic

When using this product:

• Use only as directed
• Avoid contact with eyes, mucous membranes or skin rashes.

Do not use

• On wounds or damaged skin
• If you are allergic to aspirin or salicylates or with other external analgesic products
• With a heating pad
• If you are allergic to any ingredients in this product.   

top use and consult a doctor

• If rash, itching or excessive skin irritation develops
• If condition worsens
• If symptoms last more than 7 days or clear up and occur again.

Storage and Care

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Medicated Relief

INGREDIENTS AND APPEARANCE

LEADER MEDICATED RELIEF PATCH 
camphor (synthetic) levomenthol salicylic acid patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0206
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	1.2
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	5.7
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	6.3

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
STYRENE (UNII: 44LJ2U959V)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
MINERAL OIL (UNII: T5L8T28FGP)
POLYISOBUTYLENE (1100000 MW) (UNII: FLT10CH37X)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
ZINC OXIDE (UNII: SOI2LOH54Z)
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0206-1	20 in 1 BOX	12/01/2016
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 70000-0206-2	40 in 1 BOX	12/01/2016
2		1 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	12/01/2016

Labeler - CARDINAL HEALTH, INC (097537435)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech Co., Ltd.		529128763	manufacture(70000-0206)