XRAY DOL- camphor, menthol, and methyl salicylate cream 
Genomma Lab USA, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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X Ray Pain Relief Cream 2oz 6454 ZDP

Active ingredients Purposes

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

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

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

Uses

Warnings

For external use only

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

Do not use

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

When using this product

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

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

Directions

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

Distributed by

Genomma Lab USA, Inc.

Made in China

6454

XRAY DOL 
camphor, menthol, and methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-454
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)40 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) 300 mg  in 1 g
ETHYLPARABEN (UNII: 14255EXE39)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-454-561 in 1 CARTON06/02/2022
156.7 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/02/2022
Labeler - Genomma Lab USA, Inc. (832323534)

Revised: 6/2022
Document Id: e07fef46-68da-769c-e053-2a95a90aa065
Set id: e07fef46-68d9-769c-e053-2a95a90aa065
Version: 1
Effective Time: 20220602
 
Genomma Lab USA, Inc.