HOT PAIN RELIEF- capsaicin patch patch

Estats Units - anglès - NLM (National Library of Medicine)

Compra'l ara

Fitxa tècnica Fitxa tècnica (SPC)

28-06-2017

ingredients actius:
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)
Disponible des:
Suzhou Vastech Medical Technology Co., Ltd
Designació comuna internacional (DCI):
CAPSAICIN
Composición:
CAPSAICIN 1.2 mg in 1000 mg
Vía de administración:
TOPICAL
tipo de receta:
OTC DRUG
indicaciones terapéuticas:
Uses For temporary relief associated with: - Arthritis - Backaches - Bruises - Sprains & Strains - Joint & Muscle Pain Do not use: - On the face or rashes - With a heating pad - On wounds or damaged skin - if you are allergic to any ingredients of this product Stop use and ask a doctor if: - Rash, itching or excessive skin irritation develops - Conditions worsen - Symptoms persist for more than 7 days - Symptoms clear up and occur again within a few days Directions Adults and Children 12 years of age and over: Clean and dry affected area. Peel off protective film and apply patch once or twice a day. Apply patch an hour after and before shower or bath. Patch will remain effective for 8 hours. Children Under 12 Years of Age: Consult a physician.
Estat d'Autorització:
OTC monograph not final
Número d'autorització:
71183-002-25

HOT PAIN RELIEF- capsaicin patch patch

Suzhou Vastech Medical Technology 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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Active ingredients Purpose

Capsicum Extract Capsaicin 0.025%..............................Topical Analgesic

Uses

For temporary relief associated with:

Arthritis

Backaches

Bruises

Sprains & Strains

Joint & Muscle Pain

Warnings

For external use only

Do not use:

On the face or rashes

With a heating pad

On wounds or damaged skin

if you are allergic to any ingredients of this product

When using this product:

Use only as directed

Avoid contact with the eyes, mucous membranes or rashes

Stop use and ask a doctor if:

Rash, itching or excessive skin irritation develops

Conditions worsen

Symptoms persist for more than 7 days

Symptoms clear up and occur again within a few days

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

Keep out of reach of children.

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

Directions

Adults and Children 12 years of age and over:

Clean and dry affected area.

Peel off protective film and apply patch once or twice a day.

Apply patch an hour after and before shower or bath. Patch will remain effective for 8 hours.

Children Under 12 Years of Age: Consult a physician.

Inactive ingredients

Belladonna extract, camphor, diphenhydramine, lanolin, peppermint oil, rubber, vaseline, methyl

salicylate, polyster resin, zinc oxide

Distributed by:

MCURE HEALTH SOLUTIONS INC.

20819 Currier Rd #200

City of Industry, CA 91789

MADE IN CHINA

HOT PAIN RELIEF

capsaicin patch patch

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7118 3-0 0 2

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

CAPSAICIN

1.2 mg in 10 0 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

BELLADO NNA LEAF (UNII: 6 GZW20 TIOI)

CAMPHO R ( SYNTHETIC) (UNII: 5TJD8 2A1ET)

DIPHENHYDRAMINE (UNII: 8 GTS8 2S8 3M)

PEPPERMINT O IL (UNII: AV0 9 2KU4JH)

NATURAL LATEX RUBBER (UNII: 2LQ0 UUW8 IN)

LANO LIN (UNII: 7EV6 5EAW6 H)

METHYL SALICYLATE (UNII: LAV5U50 22Y)

ZINC O XIDE (UNII: SOI2LOH54Z)

LIQ UID PETRO LEUM (UNII: 6 ZAE7X6 8 8 J)

Product Characteristics

Color

S core

S hap e

RECTANGLE (13cm*18 cm)

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7118 3-0 0 2-25

48 0 0 mg in 1 PATCH; Type 0 : No t a Co mbinatio n Pro duct

0 6 /28 /20 17

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 6 /28 /20 17

Labeler -

Suzhou Vastech Medical T echnology Co., Ltd (543772485)

Registrant -

Suzhou Vastech Medical T echnology Co., Ltd (543772485)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Suzhou Vastech Medical Technology Co., Ltd

Suzho u Vastech Medical Techno lo gy Co ., Ltd

54377248 5

ma nufa c ture (7118 3-0 0 2)

Revised: 6/2017

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