CORALITE COLD AND HOT MEDICATED- 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 Corporation
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 - with a heating pad - on a child under 12 years of age with arthritis-like conditions Stop use and ask a doctor if - condition worsens or symptoms persist for more than 7 days - symptoms clear up and occur again within a few days - excessive skin irritation occurs Directions - open pouch and remove patch - carefully peel off protective backing and apply sticky side to affected area - adults and children 12 years of age and older: - do not wear patch for more than 8 hours - apply to affected area no more than 3 times daily - children under 12 years of age: consult a doctor
Authorization status:
OTC monograph not final
Authorization number:
65923-147-02

CORALITE COLD AND HOT MEDICATED- menthol patch

United Exchange Corporation

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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90153 Coralite Cold & Hot Patch 2ct (NBE Icy Hot) (90153, 2018)

Active ingredient Purpose

Menthol 5%............................Topical analgesic

Uses

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

simple backache

arthritis

strains

bruises

sprains

For external use only

Do not use

on wounds or damaged skin

with a heating pad

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 eyes or mucous membranes

do not badnage tightly

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 symptoms persist for more than 7 days

symptoms clear up and occur again within a few days

excessive skin irritation occurs

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 (1-

800-222-1222) right away.

Directions

open pouch and remove patch

carefully peel off protective backing and apply sticky side to affected area

adults and children 12 years of age and older:

do not wear patch for more than 8 hours

apply to affected area no more than 3 times daily

children under 12 years of age: consult a doctor

Other information

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

Inactive ingredients alcohol, aluminum glycinate, glycerin, kaolin, methylparaben, polysorbate 80,

propylparaben, purified water, sodium polyacrylate, soribitan monooleate, tartaric acid, titanium dioxide

Questions or comments?

Call 1-800-814-8028 Monday-Friday 9AM-5PM (PST)

Distributed By:

UNITED EXCHANGE CORP.

5836 Corporate Ave.

Cypress, CA. 90630 USA

1-800-814-8028

Made in China

CORALITE COLD AND HOT MEDICATED

menthol patch

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 59 23-147

Route of Administration

TOPICAL

United Exchange Corporation

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

MENTHOL

50 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

DIHYDRO XYALUMINUM AMINO ACETATE ANHYDRO US (UNII: 1K713C6 15K)

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

SO DIUM PO LYACRYLATE ( 2 50 0 0 0 0 MW) (UNII: 0 5I15JNI2J)

KAO LIN (UNII: 24H4NWX5CO)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

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

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TARTARIC ACID (UNII: W48 8 8 I119 H)

SO RBITAN MO NO O LEATE (UNII: 0 6 XEA2VD56 )

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

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 59 23-147-0 2

1 in 1 POUCH

10 /23/20 18

1

1 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

10 /23/20 18

Labeler -

United Exchange Corporation (840130579)

Revised: 4/2019

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