LARGE PAIN RELIEVING- camphor menthol methyl salicytate patch

Large Pain Relieving by

Drug Labeling and Warnings

Large Pain Relieving by is a Otc medication manufactured, distributed, or labeled by Walgreen Company, Foshan Aqua Gel Biotech Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Active Ingredient: Purpose
• Camphor 3.1%: Topical Analgesic
• Menthol 6.0%: Topical Analgesic
• Methyl Salicylate 10.0%: Topical Analgesic

INACTIVE INGREDIENThydrogenated poly, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, styrene/isoprene copolymer

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.

INDICATIONS & USAGE

For temporary relief of minor aches and pains of muscles and joins: arthritis, simple backache, muscle strains, muscle sprains and bruises.

WARNINGS

For External Use Only

Allergy Alert:If prone to allergic reactions from aspirine or salicytates, consult a doctor before use.

DOSAGE & ADMINISTRATION

Adults and children over 12 years:

Clean and dry affected area. Remove patch from film, apply to affected area not more than 3-4 times a day.

Do not use for more than 8 hours.

Discard patch after use.

Reseal pouch after opening.

Children under 12 years of age, consult a physician.

If pregnant or breastfeeding

ask a health professional before use.

PURPOSE

Topical Analgesic

When using this product:

■ Use only as directed ■ Avoid contact with eyes, mucous membranes or rashes ■ Do not bandage tightly ■ Do not use at the same time as other topical analgesics ■ Dispose of used patch away from children and pets. Used patches still contain the drug product which can produce serious adverse effects if a child or pet chews or ingests the patch.

Do not use

• On wounds or damaged skin
• With a heating pad
• If you are allergic to any ingredients in this product.

Stop 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 in a few days.

Storage and Care

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

Pain Relieving Path

DIST. BY
Walgreens Co.
200 Wilmot Rd
. Deerfield, IL 60015
www.walgreens.com

TOLL-FREE CUSTOMER CARE HELP LINE Mon–Fri, 8:30 am–4:30 pm CST 866-326-1313

INGREDIENTS AND APPEARANCE

LARGE PAIN RELIEVING 
camphor menthol methyl salicytate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-9904
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	3.1 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	6.0 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED POLY(C6-14 OLEFIN; 2 CST) (UNII: P0TX083987)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
LIQUID PETROLEUM (UNII: 6ZAE7X688J)
STYRENE (UNII: 44LJ2U959V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-9904-06	6 in 1 BOX	01/01/2020
1		9 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	01/01/2020

Labeler - Walgreen Company (008965063)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech Co.,Ltd.		529128763	manufacture(0363-9904)