CORALITE EXTRA STRENGTH PAIN RELIEF SLEEVE WRIST- menthol patch

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

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Active ingredient:
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Available from:
United Exchange Corp.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Uses - temporarily relieves minor aches and pains of muscles and joints associated with - simple backache - arthritis - strains - bruises - sprains Do not use - on wounds or damaged skin - on a child under 12 years of age with arthritis-like conditions Stop use and ask a doctor if - condition worsens, or if symptoms persist for more than 7 days - symptoms clear up and occur again within a few days - redness is present or irritation or rash develops Directions - Adults and children 12 years of age and older: - open pouch and remove sleeve - remove plastic insert and discard - pull sleeve onto wrist, ankle or elbow until the colored (medicated) section of the sleeve is positioned directly over the affected area. Sleeve should feel snug, but not tight. Note: the drawings should help you understand how to do this. - apply one sleeve to affected area no more than 3 times daily - do not wear sleeve for more than 8 hours - children under 12 years of age: consult a doctor
Authorization status:
OTC monograph not final
Authorization number:
65923-122-01

CORALITE EXTRA STRENGTH PAIN RELIEF SLEEVE WRIST- menthol patch

United Exchange Corp.

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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Coralite Sleeve Patch, Wrist 90122 ZDP (2020)

Active Ingredient Purpose

Menthol 16.0%.......................................Topical Analgesic Patch

Uses

temporarily relieves minor aches and pains of muscles and joints associated with

simple backache

arthritis

strains

bruises

sprains

Warnings

For external use only

Do not use

on wounds or damaged skin

on a child under 12 years of age with arthritis-like conditions

Ask a doctor before use if you have

redness over the affected area

When using this product

use only as directed

avoid contact with the eyes, mucous membranes or rashes

do not bandage tightly over sleeve or use with a heating pad

discontinue use at least 1 hour before a bath or shower

do not use immediately after a bath or shower

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days

symptoms clear up and occur again within a few days

redness is present or irritation or rash develops

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 Poison Control Center

immediately.

Directions

Adults and children 12 years of age and older:

open pouch and remove sleeve

remove plastic insert and discard

pull sleeve onto wrist, ankle or elbow until the colored (medicated) section of the sleeve is

positioned directly over the affected area. Sleeve should feel snug, but not tight. Note: the drawings

should help you understand how to do this.

apply one sleeve to affected area no more than 3 times daily

do not wear sleeve for more than 8 hours

children under 12 years of age: consult a doctor

Other information

store at room temperature 20-25°C (68-77°F)

Inactive ingredients

carbomber 940, ethanol, ethylparaben, glycerol, propylene glycol, purified water, trolamine

Distributed by:

United Exchange Corp.

Cypress, CA 90630 USA

Made in China

CORALITE EXTRA STRENGTH PAIN RELIEF SLEEVE WRIST

menthol patch

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 59 23-122

United Exchange Corp.

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

336 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CARBO MER 9 4 0 (UNII: 4Q9 3RCW27E)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

ETHYLPARABEN (UNII: 14255EXE39 )

GLYCERIN (UNII: PDC6 A3C0 OX)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 59 23-122-0 1

1 in 1 BOX

0 2/10 /20 16

1

1 in 1 POUCH; 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 2/10 /20 16

Labeler -

United Exchange Corp. (840130579)

Revised: 3/2020

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