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NDC 70000-0206-01 Leader Medicated Relief Patch 1.2; 5.7; 6.3 1/1; 1/1; 1/1 Details

Leader Medicated Relief Patch 1.2; 5.7; 6.3 1/1; 1/1; 1/1

Leader Medicated Relief Patch is a TOPICAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by CARDINAL HEALTH, INC. The primary component is CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE.

Product Information

NDC	70000-0206
Product ID	70000-0206_d4efd80c-ce47-4b6f-e053-2a95a90a27d8
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Leader Medicated Relief Patch
Proprietary Name Suffix	n/a
Non-Proprietary Name	CAMPHOR (SYNTHETIC) LEVOMENTHOL SALICYLIC ACID
Product Type	HUMAN OTC DRUG
Dosage Form	PATCH
Route	TOPICAL
Active Ingredient Strength	1.2; 5.7; 6.3
Active Ingredient Units	1/1; 1/1; 1/1
Substance Name	CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE
Labeler Name	CARDINAL HEALTH, INC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70000-0206-01 (70000020601)

Pricing Information	N/A
NDC Package Code	70000-0206-1
Billing NDC	70000020601
Package	20 POUCH in 1 BOX (70000-0206-1) / 1 PATCH in 1 POUCH
Marketing Start Date	2016-12-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 80f68cdf-9601-495f-a7cb-fd9bdb35fde6 Details

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	12/01/2016

Labeler - CARDINAL HEALTH, INC (063997360)

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

Revised: 1/2022

Document Id: d4efd80c-ce47-4b6f-e053-2a95a90a27d8

Set id: 80f68cdf-9601-495f-a7cb-fd9bdb35fde6

Version: 3

Effective Time: 20220106