EQUATE CAPSAICIN PAIN RELIEVING- capsaicin patch

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)
Available from:
Wal-Mart Stores Inc
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Capsaicin - Topical analgesic temporarily relieves minor aches and pains of muscles and joints due to
Authorization status:
OTC monograph not final
Authorization number:
49035-890-01, 49035-890-04

EQUATE CAPSAICIN PAIN RELIEVING- capsaicin patch

Wal-Mart Stores Inc

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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Drug Facts

Active ingredient

Capsaicin 0.025%

Purpos e

Capsaicin - Topical analgesic

Us es

temporarily relieves minor aches and pains of muscles and joints due to

Warnings

For external use only

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

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

Directions

simple backache

arthritis

strains

sprains

use only as directed

do not use at least 1 hours before, or immediately after, a bath or shower

avoid contact with eyes and mucous membranes

do not apply to wounds or to damaged or very sensitive skin

do not bandage tightly or use with a heating pad

condition worsens

excessive redness, irritation, burning or discomfort of the skin develops

symptoms persist for more than 7 days or clear up and occur again within a few days

adults and children 12 years and over: apply to affected area; change patch 1 to 2 times daily

children under 12 years: ask a doctor

Inactive ingredients

carboxymethylcellulose sodium, castor oil, dihydroxyaluminum aminoacetate, edetate disodium,

glycerin, methylparaben, partially neutralized polyacrylate, polyacrylic acid, polysorbate 80, polyvinyl

alcohol, propylene glycol monocaprylate, purified water, sodium polyacrylate, sodium polyacrylate

starch, sorbitol solution, talc, tartaric acid

Questions or comments?

Call1-888-287-1915

Package/Label Principal Display Panel

FOR BEST RESULTS: apply to clean, dry skin

tear open pouch and remove patch; if desired, cut patch to size

grasp both ends of the patch firmly with thumbs near center

stretch patch until the backing separates

remove protective film while applying patch directly to site of pain

WASH HANDS WITH SOAP AND WATER AFTER APPLYING

Principal Display Panel

EQUATE CAPSAICIN PAIN RELIEVING

capsaicin patch

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:49 0 35-8 9 0

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Wal-Mart Stores Inc

Ingredient Name

Basis of Strength

Stre ng th

CAPSAICIN (UNII: S0 7O44R1ZM) (CAPSAICIN - UNII:S0 7O44R1ZM)

CAPSAICIN

0 .25 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

CARBO XYMETHYLCELLULO SE SO DIUM, UNSPECIFIED FO RM (UNII: K6 79 OBS311)

CASTO R O IL (UNII: D5340 Y2I9 G)

DIHYDRO XYALUMINUM AMINO ACETATE (UNII: DO250 MG0 W6 )

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

GLYCERIN (UNII: PDC6 A3C0 OX)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PO LYACRYLIC ACID ( 2 50 0 0 0 MW) (UNII: 9 G2MAD7J6 W)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

PO LYVINYL ALCO HO L, UNSPECIFIED (UNII: 532B59 J9 9 0 )

PRO PYLENE GLYCO L CAPRYLATE (UNII: RT9 P9 S0 9 QI)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM PO LYACRYLATE ( 8 0 0 0 MW) (UNII: 28 5CYO341L)

SO RBITO L (UNII: 50 6 T6 0 A25R)

TALC (UNII: 7SEV7J4R1U)

TARTARIC ACID (UNII: W48 8 8 I119 H)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:49 0 35-8 9 0 -0 1

1 in 1 POUCH

0 1/0 1/20 18

1

0 .0 0 35 g in 1 PATCH; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:49 0 35-8 9 0 -0 4

4 in 1 POUCH

0 1/0 1/20 18

2

0 .0 0 35 g in 1 PATCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 1/0 1/20 18

Labeler -

Wal-Mart Stores Inc (051957769)

Revised: 12/2019

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