NDC | 66902-230-03 |
Set ID | 5d405cc2-907b-49dd-a5b6-118dfb370043 |
Category | HUMAN OTC DRUG LABEL |
Packager | NATURAL ESSENTIALS, INC |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART348 |
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Use
-
Warnings
For external use only
Do not use
- if you are allergic to any ingredient in this product
- on large areas of the body or on cut, irritated or swollen skin
- on puncture wounds
- for more than one week without consulting a doctor
Ask a doctor or pharmacist before use if you are
- using blood thinning medications, steroids or non-steroidal anti-inflammatory drugs (NSAIDS)
When using this product
- do not use other topical products
- avoid contact with eyes or mucous membranes
- do not bandage tightly or apply local heat (such as heating pads) to area of use or with a medicated patch
- keep away from excessive heat
- Directions
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ZIMS LIDO FREEZE
menthol, unspecified form and lidocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66902-230 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 10 mg in 1 mL LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ALCOHOL (UNII: 3K9958V90M) ARNICA MONTANA (UNII: O80TY208ZW) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL ALCOHOL (UNII: ND2M416302) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66902-230-03 89 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 08/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/01/2016 Labeler - NATURAL ESSENTIALS, INC (947484713) Establishment Name Address ID/FEI Business Operations NATURAL ESSENTIALS, INC 947484713 MANUFACTURE(66902-230)