Label: ELITE PAIN RELIEF- allantoin, lidocaine, petrolatum patch
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Contains inactivated NDC Code(s)
NDC Code(s): 69418-004-15 - Packager: Meds Direct Rx, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 November 18, 2015
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS:
- PURPOSE
- USES:
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WARNINGS:
•For external use only.
•Avoid contact with eyes.
•Stop use and ask a doctor if condition worsens, or symptoms last more than 7 days, or clear up and occur again within a few days.
•Do not use on deep or puncture wounds, animal bites, or serious burns.
•If pregnant or breast feeding, contact physician prior to use.
• Do not use in large quantities, particularly over raw surfaces or blistered areas.
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS:
- INACTIVE INGREDIENTS:
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- Package Labeling
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INGREDIENTS AND APPEARANCE
ELITE PAIN RELIEF
allantoin, lidocaine, petrolatum patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69418-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 2 g in 100 g LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 30 g in 100 g Inactive Ingredients Ingredient Name Strength ONION (UNII: 492225Q21H) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69418-004-15 15 g in 1 PATCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 05/05/2015 Labeler - Meds Direct Rx, Inc. (064053428) Establishment Name Address ID/FEI Business Operations Meds Direct Rx, Inc. 064053428 relabel(69418-004) , repack(69418-004) Establishment Name Address ID/FEI Business Operations Foshan Aqua Gel Biotech Co. Ltd 529128763 manufacture(69418-004)
