ASPERCREME WARMING PATCH- capsaicin patch

Aspercreme by

Drug Labeling and Warnings

Aspercreme by is a Otc medication manufactured, distributed, or labeled by Lead Chemical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Capsaicin 0.025%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

• arthritis
• simple backache
• muscle strains
• sprains
• bruises
• cramps

Warnings

For external use only

When using this product

• read inside of carton before using
• use only as directed. Read and follow all directions and warnings on this pouch.
• avoid contact with the eyes and mucous membranes
• rare cases of serious burns have been reported with products of this type
• do not bandage tightly or apply local heat (such as heating pads)
• do not apply to wounds or damaged, broken or irritated skin
• do not use at the same time as other topical analgesics
• discontinue use at least 1 hour before a bath or shower
• a transient burning sensation may occur upon application but generally disappears in several days
• if severe burning occurs, discontinue use immediately and read inside carton for important information
• dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop use and ask a doctor if

• condition worsens
• redness is present
• irritation develops
• symptoms persist for more than 7 days or clear up and occur again within a few days
• you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

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

If pregnancy or breast feeding,

ask a health professional before use

Keep out of reach of children and pets.

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

Directions

adults 18 years of age and older:

• clean and dry affected area
• remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
• carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
• once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
• apply one patch to affected area for up to 8 hours, repeat as necessary, but no more than 3 times a day
• AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

children under 18 years of age: ask a doctor

Inactive ingredients

aluminum hydroxide, benzyl alcohol, cellulose gum, disodium EDTA, glycerin, isopropyl myristate, methyl acrylate/2-ethylhexyl acrylate copolymer, nonoxynol-30, polyacrylic acid, polysorbate 80, sodium polyacrylate, starch/acrylic acid graft copolymer sodium salt, talc, tartaric acid, titanium dioxide, tocopherol, water

Package/Label Principal Display Panel

Cut Open Pouch and Remove Pad
Reseal Pouch After Opening

ODOR FREE
Aspercreme®
WARMING
PAIN RELIEF PATCH
THE NUMBER ONE #1 ODOR FREE BRAND1

Contains 5 Patches in 1 Resealable Pouch
3-15/16” x 5-1/2” (10 cm x 14 cm) each
Pain Relieving Ointment on a Breathable Adhesive Pad     0.025% Capsaicin

Label

INGREDIENTS AND APPEARANCE

ASPERCREME  WARMING PATCH
capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62168-0589
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	1.506 mg

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
NONOXYNOL-30 (UNII: JJX07DG188)
TALC (UNII: 7SEV7J4R1U)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62168-0589-1	120 in 1 CARTON	01/02/2019
1		5 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	01/02/2019

Labeler - Lead Chemical Co., Ltd. (693727091)

Registrant - Lead Chemical Co., Ltd. (693727091)

Establishment
Name	Address	ID/FEI	Business Operations
Lead Chemical Co., Ltd.		718216992	MANUFACTURE(62168-0589)