Label: RAY DOL- menthol and methyl salicylate cream
- NDC Code(s): 50066-057-73
- Packager: Genomma Lab USA Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Drug Facts
- Active Ingredients
Menthol - 10%
Methyl salicylate - 15%Close
Temporary relief of minor aches and pains of muscle and joints associated with
- simple back aches
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 OUT OF REACH OF CHILDREN
Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.Close
- 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, TriethanolamineClose
- Principal Display Panel - 3.0 oz Carton
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 Tube
Pain Relieving Cream
Net WT. 3.0 oz (85g)
- INGREDIENTS AND APPEARANCE
pain relieving cream cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50066-057 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 100 mg in 1 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 150 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER 940 (UNII: 4Q93RCW27E) CETYL ALCOHOL (UNII: 936JST6JCN) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50066-057-73 1 in 1 CARTON 1 85 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/15/2013 Labeler - Genomma Lab USA Inc. (832323534) Registrant - Faria LLC dba Sheffield Pharmaceuticals (151177797) Establishment Name Address ID/FEI Business Operations Faria LLC dba Sheffield Pharmaceuticals 151177797 manufacture(50066-057)