Your browser does not support JavaScript! RAY DOL (PAIN RELIEVING CREAM) CREAM [GENOMMA LAB USA INC.]
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RAY DOL (pain relieving cream) cream
[Genomma Lab USA Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Drug Facts

Active Ingredients

Menthol - 10%

Methyl salicylate - 15%

Purpose

Topical Analgesic

Topical Analgesic

Uses

Temporary relief of minor aches and pains of muscle and joints associated with

  • simple back aches
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only

Do not use

  • on wounds, damaged, broken or irritated skin
  • with a heating pad

When using this product

  • use only as directed
  • avoid contact with eyes or mucous membranes
  • Do not apply bandage tightly

Stop use and ask doctor if

  • Condition worsens, or symtoms persist for more than 7 days
  • symptoms  clear up and occur again within a few days
  • excessive skin irritation occurs
  • If pregnant or breast feeding, ask a health professional before use.

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  • Adults and children 2 years of age and older; Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age; consult a doctor.

Other information

  • Store at controlled room temperature 20°- 25°C ( 68° to 77°F)
  • Close cap tightly after use.

Inactive ingredients

Carbomer, Cetyl Alcohol, Oleth-3 Phosphate, Purified Water, Stearic acid, Triethanolamine

Principal Display Panel - 3.0 oz Carton

RAY DOL

Topical Analgesic

Greaselees Stainless

Temporary Relief

Penetrating temporary relief of minor muscle aches

For Arthritis, Muscle & Joint Pain

10% Menthol and

15% Methyl Salicylate

Net WT. 3.0 oz ( 85g)

Principal Display Panel - 3.0 oz Carton

Principal Display Panel - 3.0 oz Tube

RAY DOL

Pain Relieving Cream

Topical Analgesic

Net WT. 3.0 oz (85g)

Principal Display Panel - 3.0 oz Tube

RAY DOL 
pain relieving cream cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50066-057
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL100 mg  in 1 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE150 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER 940 
CETYL ALCOHOL 
TROLAMINE 
WATER 
STEARIC ACID 
OLETH-3 PHOSPHATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-057-731 in 1 CARTON
185 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/15/2013
Labeler - Genomma Lab USA Inc. (832323534)
Registrant - Faria LLC dba Sheffield Pharmaceuticals (151177797)
Establishment
NameAddressID/FEIBusiness Operations
Faria LLC dba Sheffield Pharmaceuticals151177797manufacture(50066-057)

Revised: 1/2014
 
Genomma Lab USA Inc.

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