Xray®

Xray®
SPL v1
SPL
SPL Set ID 5244ddee-fd9e-4df3-8fb3-b16aa321a316
Route
TOPICAL
Published
Effective Date 2023-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, (+)- (100 mg) Camphor, (-)- (40 mg) Salicylic Acid (300 mg)
Inactive Ingredients
Glyceryl Monostearate Water Polysorbate 80 Sorbitan Monooleate Stearic Acid Ethylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-26

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • temporarily relieves the minor aches and pains of muscles and joints associated with:
    • sprains
    • simple backache
    • arthritis
    • strains
    • bruises
Section 42229-5

Drug Facts

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 50569-3

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

Section 53414-9

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

Section 55105-1
Active ingredients Purpose
Camphor 4% Topical analgesic
Menthol 10% Topical analgesic
Methyl salicylate 30% Topical analgesic
Warnings

For external use only

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
Do Not Use
  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions
Allergy Alert

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

Other Information

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

Inactive Ingredients

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

Questions Or Comments?

Call toll free 1 877 994 3666

Monday to Friday 8:00 am – 6:00 pm CST

When Using This Product
  • do not use otherwise than as directed
  • avoid contact with eyes, mucous membranes or rashes
  • do not bandage tightly
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
Principal Display Panel 56.7 G Tube Carton

X RAY®

DOL

ULTRA STRENGTH

Pain Relief Cream

FOR DAILY TREATMENT OF

ARTHRITIS AND JOINT PAIN*

DEEP PENETRATING

FAST ACTING

RELIEF

Topical Analgesic

*See Drug Facts for more information

Camphor 4%

Menthol 10%

Methyl salicylate 30%

NET WT.

2 OZ (56.7 G)


Structured Label Content

Uses
  • temporarily relieves the minor aches and pains of muscles and joints associated with:
    • sprains
    • simple backache
    • arthritis
    • strains
    • bruises
Section 42229-5 (42229-5)

Drug Facts

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 50569-3 (50569-3)

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients Purpose
Camphor 4% Topical analgesic
Menthol 10% Topical analgesic
Methyl salicylate 30% Topical analgesic
Warnings

For external use only

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
Do Not Use (Do not use)
  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions
Allergy Alert (Allergy alert)

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

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call toll free 1 877 994 3666

Monday to Friday 8:00 am – 6:00 pm CST

When Using This Product (When using this product)
  • do not use otherwise than as directed
  • avoid contact with eyes, mucous membranes or rashes
  • do not bandage tightly
Stop Use and Ask A Doctor If (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
Principal Display Panel 56.7 G Tube Carton (PRINCIPAL DISPLAY PANEL - 56.7 G Tube Carton)

X RAY®

DOL

ULTRA STRENGTH

Pain Relief Cream

FOR DAILY TREATMENT OF

ARTHRITIS AND JOINT PAIN*

DEEP PENETRATING

FAST ACTING

RELIEF

Topical Analgesic

*See Drug Facts for more information

Camphor 4%

Menthol 10%

Methyl salicylate 30%

NET WT.

2 OZ (56.7 G)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)