Label: RAY DOL- pain relieving cream cream
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Contains inactivated NDC Code(s)
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
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.
Drug Label Information
Updated January 7, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
- Uses
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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 OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Principal Display Panel - 3.0 oz Carton
- Principal Display Panel - 3.0 oz Tube
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INGREDIENTS AND APPEARANCE
RAY DOL
pain relieving cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50066-057 Route of Administration TOPICAL 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)