Coralite Pain Relief menthol Patch 2 ct. 90150 ZDP

Manufacturer
United Exchange Corp.
Effective date
2025-10-21
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:40:19

Key Label Information#

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Drug Facts Active ingredient Purpose Menthol 5%......................................................Topical analgesic

OTC - PURPOSE SECTION

Uses temporarily relieves minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Warnings For external use only

OTC - DO NOT USE SECTION

Do not use on wounds or damaged skin with a heating pad on a child under 12 years of age with arthritis-like conditions

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

Distributed by: United Exchange Corp. Cypress, CA 90630 USA Made in China

Other Label Information

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

Inactive ingredients alcohol, aluminum glycinate, glycerin, kaolin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide

Label Images#

90150.1
90150.1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65923-205-02Coralite Cold and Hot2 in 1 POUCHPATCH27
65923-205-02Coralite Cold and Hot1 in 1 PATCHPATCH17

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65923-20565923-205-02

Ingredients#

Complete SPL Sections#

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Drug Facts Active ingredient Purpose Menthol 5%......................................................Topical analgesic

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Uses temporarily relieves minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains

WARNINGS SECTION

WARNINGS SECTION

Warnings For external use only

OTC - DO NOT USE SECTION

OTC - DO NOT USE SECTION

Do not use on wounds or damaged skin with a heating pad on a child under 12 years of age with arthritis-like conditions

OTC - ASK DOCTOR SECTION

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have redness over the affected area

OTC - WHEN USING SECTION

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

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

STORAGE AND HANDLING SECTION

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Inactive ingredients alcohol, aluminum glycinate, glycerin, kaolin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

Distributed by: United Exchange Corp. Cypress, CA 90630 USA Made in China

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62025-01-09full-release2026-06-01 00:52:09