CORALITE COLD AND HOT- 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 - 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:
65923-205-02

CORALITE COLD AND HOT- 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 Pain Relief menthol Patch 2 ct. 90150 (2019)

Drug Facts

Active ingredient Purpose

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

Us es

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

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 bandage 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, sorbitan monooleate, tartaric acid, titanium dioxide

Distributed by:

United Exchange Corp.

Cypress, CA 90630 USA

Made in China

CORALITE COLD AND HOT

menthol patch

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 59 23-20 5

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

5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

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

TARTARIC ACID (UNII: W48 8 8 I119 H)

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

KAO LIN (UNII: 24H4NWX5CO)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

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

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

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

WATER (UNII: 0 59 QF0 KO0 R)

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

METHYLPARABEN (UNII: A2I8 C7HI9 T)

GLYCERIN (UNII: PDC6 A3C0 OX)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 59 23-20 5-0 2

2 in 1 POUCH

0 4/0 4/20 19

1

1 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 4/0 4/20 19

Labeler -

United Exchange Corp. (840130579)

Revised: 9/2019

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