Label: BLUE ICE ANALGESIC GEL- menthol gel
- NDC Code(s): 15127-452-08
- Packager: Select Brand Distributors
- 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 October 7, 2014
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- Active Ingredient
- 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 of age and older: Apply liberally to painful area and massage until gel is absorbed into skin. Repeat no more than 3-4 times daily.
- For external use only.
- Avoid contact with eyes and mucus membranes.
When using this product, do not:
- use with heating pads or heating devices
- use, pour, spill or store near open flame
- use with other creams, sprays or liniments
- apply to damaged skin or wounds
- bandage area tightly
To do so may result in excessive skin irritation or skin burn.
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.
- PRINCIPAL DISPLAY PANEL
- INACTIVE INGREDIENTS
- Keep out of reach of children
INGREDIENTS AND APPEARANCE
BLUE ICE ANALGESIC GEL
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:15127-452 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.0 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 88.05 g in 100 g ISOPROPYL ALCOHOL (UNII: ND2M416302) 8.91 g in 100 g CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) 0.667 g in 100 g THYMOL (UNII: 3J50XA376E) 0.2 g in 100 g AMMONIA (UNII: 5138Q19F1X) 0.06 g in 100 g SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.1 g in 100 g MAGNESIUM SULFATE (UNII: DE08037SAB) 0.01 g in 100 g FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.003 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:15127-452-08 227 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/06/2014 Labeler - Select Brand Distributors (043562370) Establishment Name Address ID/FEI Business Operations Delon Laboratories (1990) Ltd 243387722 label(15127-452) , manufacture(15127-452) , pack(15127-452)