Label: ICE COLD ANALGESIC- menthol gel
- 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.
Updated August 26, 2011
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- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
For external use only
Do not use with other topical pain relievers, with heating pads or heating devices
When using this product do not use in or near eyes, do not apply to wounds or damaged skin
do not bandage tightly
Stop use and ask doctor if condition worsens, symptoms last more than days or clear up and occur again within a few days, redness or irritation develops
If pregnant or breast feeding ask a health professional before use.
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ICE COLD ANALGESIC
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:29500-9034 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.27 g in 227 g Inactive Ingredients Ingredient Name Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) SODIUM HYDROXIDE (UNII: 55X04QC32I) THYMOL (UNII: 3J50XA376E) WATER (UNII: 059QF0KO0R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:29500-9034-6 227 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/01/2011 Labeler - Personal Care Products (966155082) Registrant - Personal Care Products (966155082) Establishment Name Address ID/FEI Business Operations Ningbo Liyuan Daily Chemical Products Co Ltd 530766098 manufacture