Label: PAIN RELIEF LIQUID- menthol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 64092-402-02 - Packager: Great Lakes Wholesale, Marking, and Sales, Inc.
- Category: HUMAN OTC DRUG LABEL
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 December 5, 2016
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
For external use only
When using this product
- use only as directed
- do not bandage tightly or use with a heating pad
- avoid contact with eyes and mucous membranes
- do not apply to wounds or damaged, broken or irritated skin
- a transient burning sensation may occur upon application but generally disappears in several days
- if severe burning sensation occurs, discontinue use immediately
- do not expose the area treated with product to heat or direct sunlight
Flammable
- keep away from fire or flame
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- INSTRUCTIONS FOR USE
- INACTIVE INGREDIENT
- DESCRIPTION
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAIN RELIEF LIQUID
menthol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64092-402 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.16 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) CAPSAICIN (UNII: S07O44R1ZM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64092-402-02 73 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 12/05/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/05/2016 Labeler - Great Lakes Wholesale, Marking, and Sales, Inc. (361925498) Registrant - Illinois Industrial Tool, Inc (628032898) Establishment Name Address ID/FEI Business Operations Jiangsu Dedi Medical Device Co., Ltd. 421353662 manufacture(64092-402)