Label: DR. BLUE- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 10578-035-03, 10578-035-04, 10578-035-05 - Packager: Indiana Botanic Gardens
- Category: HUMAN OTC DRUG LABEL
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 September 26, 2014
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- Drug Facts
- 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:10578-035 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 3.89 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) EMU OIL (UNII: 344821WD61) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GLUCOSAMINE SULFATE (UNII: 1FW7WLR731) GLYCERIN (UNII: PDC6A3C0OX) IMIDUREA (UNII: M629807ATL) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALCOHOL (UNII: 3K9958V90M) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Product Characteristics Color BLUE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10578-035-03 71 g in 1 JAR 2 NDC:10578-035-04 142 g in 1 JAR 3 NDC:10578-035-05 57 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/01/2003 Labeler - Indiana Botanic Gardens (005421771) Establishment Name Address ID/FEI Business Operations Indiana Botanic Gardens 005421771 manufacture(10578-035)