Label: ASSURED ICE COLD TOPICAL ANALGESIC - camphor (synthetic) and menthol gel
- NDC Code(s): 33992-7993-8
- Packager: Greenbrier International, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active Ingredients
for the temporary relief of minor aches and pains of muscles and jointsClose
For external use only. Avoid contact with eyes.
Ask a doctor before use if you have cough associated with
persistent or chronic coughClose
- When using this product do not
add to hot water or any container where healing water may cause splattering and result in burns
use in eyes or directly on mucous membranes
take by mouth or place in nostrils
apply to wounds or damaged skin
- Consult a doctor and discontinue use
if condition worsens, persist for more than 1 week or tends to recurClose
- Keep out of reach of children.
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.Close
see important warnings under "When using this product"
adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily
children under 2 years of age: consult a physician.Close
- Other information
store at 20 to 25 degreesC ( 68 to 77degrees F)
- Inactive Ingredients
carbomer, FDandC blue no. 1, isopropyl alcohol, methylchloroisothiasolinone, methylisothiazolinone, sodium hydroxide, water.Close
- PRINCIPAL DISPLAY PANEL
Assured ICE COLD
Topical Analgesic Gel
Net wt 8oz (227g)
GREENBRIER INTERNATIONAL, INC.
CHESAPEAKE, VA 23320
MADE IN CHINAClose
- INGREDIENTS AND APPEARANCE
ASSURED ICE COLD TOPICAL ANALGESIC
camphor, menthol gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-7993 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 3.0 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1.25 g in 100 g Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ISOPROPYL ALCOHOL (UNII: ND2M416302) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33992-7993-8 227 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/06/2011 Labeler - Greenbrier International, Inc. (610322518)