Label: DR. BLUE- menthol gel
- NDC Code(s): 10578-131-02, 10578-131-05
- Packager: Indiana Botanic Gardens
- 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.
Drug Label Information
Updated November 1, 2016
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- Active Ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
- Directions
- Other Information:
- Inactive Ingredients
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DR. BLUE
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10578-131 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 4.58 g in 100 g Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TROLAMINE (UNII: 9O3K93S3TK) IMIDUREA (UNII: M629807ATL) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALCOHOL (UNII: 3K9958V90M) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) EMU OIL (UNII: 344821WD61) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) GLYCERIN (UNII: PDC6A3C0OX) GLUCOSAMINE SULFATE (UNII: 1FW7WLR731) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color BLUE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10578-131-02 57 g in 1 TUBE; Type 0: Not a Combination Product 11/01/2016 2 NDC:10578-131-05 142 g in 1 JAR; Type 0: Not a Combination Product 11/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/01/2016 Labeler - Indiana Botanic Gardens (005421771) Establishment Name Address ID/FEI Business Operations Indiana Botanic Gardens 005421771 manufacture(10578-131)