NDC | 64092-402-02 |
Set ID | 42eef404-1d3a-5991-e054-00144ff8d46c |
Category | HUMAN OTC DRUG LABEL |
Packager | Great Lakes Wholesale, Marking, and Sales, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
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
-
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)