ASPERCREME WARMING PATCH- capsaicin patch 
Lead Chemical Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Aspercreme Warming Pain Relief Patch

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

image-01

Label

ASPERCREME  WARMING PATCH
capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-0589
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN1.506 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62168-0589-1120 in 1 CARTON01/02/201904/30/2022
15 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/02/201904/30/2022
Labeler - Lead Chemical Co., Ltd. (693727091)
Registrant - Lead Chemical Co., Ltd. (693727091)
Establishment
NameAddressID/FEIBusiness Operations
Lead Chemical Co., Ltd.718216992MANUFACTURE(62168-0589)

Revised: 10/2020
 
Lead Chemical Co., Ltd.