Coralite Ultra Strength Pain Relief Balm 0.63oz (532)

SPL v13

SPL

SPL Set ID 44ecf959-cc07-4adc-a500-075b2ee69548

Route

TOPICAL

Published

Effective Date 2014-10-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Camphor (synthetic) (110 mg) Menthol

Inactive Ingredients

Peppermint Clove Oil Petrolatum Paraffin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2014-10-15

Description

Active ingredients Purpose Camphor 11%........................................................ Topical analgesic Menthol 11%.......................................................... Topical analgesic

Medication Information

Warnings and Precautions

Warnings

For external use only

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

Indications and 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

Dosage and Administration

Distributed by:

United Exchange Corp.

Cypress, CA 90630 USA

1-888-645-8204

Made in China

Description

Section 44425-7

Other information

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

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

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

Section 50567-7

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

Section 50570-1

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

Section 51727-6

Inactive ingredients

clove oil, paraffin, peppermint oil, petrolatum

Section 51945-4

Section 53414-9

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

Section 55105-1

Uses

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

Section 55106-9

Active ingredients Purpose

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

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

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Distributed by:

United Exchange Corp.

Cypress, CA 90630 USA

1-888-645-8204

Made in China

Warnings and Precautions (34071-1)

Warnings

For external use only

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

Section 44425-7 (44425-7)

Other information

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

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients

clove oil, paraffin, peppermint oil, petrolatum

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Uses

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

Section 55106-9 (55106-9)

Active ingredients Purpose

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

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

Advanced Ingredient Data

[{"name": "PEPPERMINT", "unii": "V95R5KMY2B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CLOVE OIL", "unii": "578389D6D0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PARAFFIN", "unii": "I9O0E3H2ZE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "ACTIB", "strengthNumerator": "110", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "110", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "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", "34068-7": "Distributed by: United Exchange Corp. Cypress, CA 90630 USA 1-888-645-8204 Made in China", "34071-1": "Warnings For external use only Allergy alert: This product may cause allergic reaction in some individuals. Test on small area before use.", "44425-7": "Other information store at room temperature 20-25°C (68-77°F)", "50565-1": "Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately", "50566-9": "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", "50567-7": "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", "50570-1": "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", "51727-6": "Inactive ingredients clove oil, paraffin, peppermint oil, petrolatum", "53414-9": "If pregnant or breast feeding, ask a healthcare professional before use", "55105-1": "Uses temporarily relieves minor aches and pains of muscles and joints associated with simple backache arthritis strains bruise sprains", "55106-9": "Active ingredients Purpose Camphor 11%........................................................ Topical analgesic Menthol 11%.......................................................... Topical analgesic"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:57.700218 · Updated: 2026-03-14T23:13:18.140905