Label: EQUALINE BLUE ICE PAIN RELIEVING- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 41163-488-32 - Packager: SUPERVALU INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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.
Drug Label Information
Updated October 3, 2011
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- WHEN USING
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STOP USE
If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product
and consult a physician. If you have sensitive skin, consult a physician. If skin irritation develops, discontinue use and seek the advice of a physician before
using this product.
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Directions:
- See important warnings under "When using this product."
- Do not apply to children under 2 years of age, unless advised by a physician
- Adults and children over 2 years and older: Apply liberally to painful area and massage until gel is absorbed into skin. Repeat no more than 3-4 times daily
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EQUALINE BLUE ICE PAIN RELIEVING
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-488 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOPROPYL ALCOHOL (UNII: ND2M416302) THYMOL (UNII: 3J50XA376E) AMMONIA (UNII: 5138Q19F1X) SODIUM HYDROXIDE (UNII: 55X04QC32I) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41163-488-32 227 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part348 10/03/2011 Labeler - SUPERVALU INC (006961411)