X Ray Pain Relief Cream 2oz 6454 Zdp

SPL v3

SPL

SPL Set ID e07fef46-68d9-769c-e053-2a95a90aa065

Route

TOPICAL

Published

Effective Date 2022-06-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Camphor (synthetic) (40 mg) Menthol (100 mg)

Inactive Ingredients

Methyl Salicylate Ethylparaben Glyceryl Monostearate Polysorbate 80 Water Sorbitan Monooleate Stearic Acid

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-06-02

Description

Active ingredients Purposes Camphor 4%...................................Topical analgesic Menthol 10%...................................Topical analgesic Methyl salicylate 30%......................Topical analgesic

Medication Information

Warnings and Precautions

Warnings

For external use only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Indications and Usage

Directions

use only as directed
adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
children under 12 years of age: ask a doctor

Dosage and Administration

Distributed by

Genomma Lab USA, Inc.

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 (1-800-222-1222) right away

Section 50567-7

When using this product

do not use otherwise than as directed
avoid contain with the eyes, mucous membranes or rashes
do not bandage tightly

Section 50569-3

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

Section 50570-1

Do not use

on wounds or damaged skin
with a heating pad
on a child under 12 years of age with arthritis-like conditions

Section 51727-6

Inactive ingredients

ethylparaben, glyceryl monostearate, polysorbate 80, purified water, sorbitan monooleate, stearic acid

Section 51945-4

Section 53414-9

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

Section 55105-1

Uses

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

Section 55106-9

Active ingredients Purposes

Camphor 4%...................................Topical analgesic

Menthol 10%...................................Topical analgesic

Methyl salicylate 30%......................Topical analgesic

Structured Label Content

Indications and Usage (34067-9)

Directions

use only as directed
adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
children under 12 years of age: ask a doctor

Dosage and Administration (34068-7)

Distributed by

Genomma Lab USA, Inc.

Made in China

Warnings and Precautions (34071-1)

Warnings

For external use only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor 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 (1-800-222-1222) right away

Section 50567-7 (50567-7)

When using this product

do not use otherwise than as directed
avoid contain with the eyes, mucous membranes or rashes
do not bandage tightly

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

Do not use

on wounds or damaged skin
with a heating pad
on a child under 12 years of age with arthritis-like conditions

Section 51727-6 (51727-6)

Inactive ingredients

ethylparaben, glyceryl monostearate, polysorbate 80, purified water, sorbitan monooleate, stearic acid

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Uses

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

Section 55106-9 (55106-9)

Active ingredients Purposes

Camphor 4%...................................Topical analgesic

Menthol 10%...................................Topical analgesic

Methyl salicylate 30%......................Topical analgesic

Advanced Ingredient Data

[{"name": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "ACTIB", "strengthNumerator": "40", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "METHYL SALICYLATE", "unii": "LAV5U5022Y", "classCode": "IACT", "strengthNumerator": "300", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "ETHYLPARABEN", "unii": "14255EXE39", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL MONOSTEARATE", "unii": "230OU9XXE4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN MONOOLEATE", "unii": "06XEA2VD56", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Directions use only as directed adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor", "34068-7": "Distributed by Genomma Lab USA, Inc. Made in China", "34071-1": "Warnings For external use only Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor 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 (1-800-222-1222) right away", "50567-7": "When using this product do not use otherwise than as directed avoid contain with the eyes, mucous membranes or rashes do not bandage tightly", "50569-3": "Ask a doctor before use if you have redness over the affected area.", "50570-1": "Do not use on wounds or damaged skin with a heating pad on a child under 12 years of age with arthritis-like conditions", "51727-6": "Inactive ingredients ethylparaben, glyceryl monostearate, polysorbate 80, purified water, sorbitan monooleate, stearic acid", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Uses temporarily relieves the minor aches and pains of muscles and joints associated with sprains simple backache arthritis strains bruises", "55106-9": "Active ingredients Purposes Camphor 4%...................................Topical analgesic Menthol 10%...................................Topical analgesic Methyl salicylate 30%......................Topical analgesic"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:00.037880 · Updated: 2026-03-14T23:13:20.000214