CORALITE ULTRA STRENGTH PAIN RELIEF- camphor menthol ointment

Coralite Ultra Strength Pain Relief by

Drug Labeling and Warnings

Coralite Ultra Strength Pain Relief by is a Otc medication manufactured, distributed, or labeled by United Exchange Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                       Purpose

Camphor 11%........................................................ Topical analgesic

Menthol 11%.......................................................... Topical analgesic

PURPOSE

Uses

• temporarily relieves minor aches and pains of muscles and joints associated with
• simple backache
• arthritis
• strains
• bruise
• sprains

WARNINGS

Warnings

For external use only

Allergy alert: This product may cause allergic reaction in some individuals. Test on small area before use.

DO NOT USE

Do not use

• on wounds, damaged or irritated skin
• with a heating pad
• if you are allergic to any ingredients of this product
• on a child under 12 years of age with arthritis-like conditions

WHEN USING

When using this product

• do not use otherwise than as directed
• avoid contact with the eyes, mucous membranes or rashes
• 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

Stop use and ask a doctor if

• redness is present or irritation or rash develops
• condition worsens or symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days

PREGNANCY OR BREAST FEEDING

If pregnant or breast feeding, ask a healthcare professional before use

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center immediately

INDICATIONS & USAGE

Directions

• adults and children 12 years of age and older:
• rub well on the affected area. Repeat 3 to 4 times daily.
• children under 12 years of age: consult a doctor

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

clove oil, paraffin, peppermint oil, petrolatum

DOSAGE & ADMINISTRATION

Distributed by:

United Exchange Corp.

Cypress, CA 90630 USA

1-888-645-8204

Made in China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CORALITE ULTRA STRENGTH PAIN RELIEF 
camphor menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-532
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	110 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	110 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PEPPERMINT OIL (UNII: AV092KU4JH)
CLOVE OIL (UNII: 578389D6D0)
PETROLATUM (UNII: 4T6H12BN9U)
PARAFFIN (UNII: I9O0E3H2ZE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-532-18	1 in 1 CARTON	12/13/2017
1		18 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/15/2014

Labeler - United Exchange Corp. (840130579)