Label: BIOTEMPER- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 71718-333-01, 71718-333-02, 71718-333-04, 71718-333-05, view more71718-333-07, 71718-333-09, 71718-333-11, 71718-333-13, 71718-333-15 - Packager: Scientific Solutions Global, LLC
- 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 January 29, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Uses
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Warnings
For external use only
Flammable keep away from fire or flame
When using this product • avoid contact with eyes or mucous membranes • do not bandage tightly • do not apply to wound or damaged or irritated skin
Stop use and consult a doctor if • condition worsens • symptoms persist for more than 7 days • clear up and occur again within a few days
If pregnant or breast-feeding, ask a health professional before use - KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive Ingredients
- Other Information
- Questions or Comments?
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
BIOTEMPER
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71718-333 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 10 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ARNICA MONTANA (UNII: O80TY208ZW) FRANKINCENSE (UNII: R9XLF1R1WM) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) FRANKINCENSE OIL (UNII: 67ZYA5T02K) GREEN TEA LEAF (UNII: W2ZU1RY8B0) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) ISOPROPYL ALCOHOL (UNII: ND2M416302) LAVENDER OIL (UNII: ZBP1YXW0H8) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TEA TREE OIL (UNII: VIF565UC2G) THYMOL (UNII: 3J50XA376E) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71718-333-01 118 mL in 1 JAR; Type 0: Not a Combination Product 09/01/2017 2 NDC:71718-333-02 2 in 1 PACKAGE 09/01/2017 2 118 mL in 1 JAR; Type 0: Not a Combination Product 3 NDC:71718-333-04 118 mL in 1 TUBE; Type 0: Not a Combination Product 09/01/2017 4 NDC:71718-333-05 2 in 1 PACKAGE 09/01/2017 4 118 mL in 1 TUBE; Type 0: Not a Combination Product 5 NDC:71718-333-07 237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 09/01/2017 6 NDC:71718-333-09 452 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 09/01/2017 7 NDC:71718-333-11 946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 09/01/2017 8 NDC:71718-333-13 1893 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 09/01/2017 9 NDC:71718-333-15 3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 09/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/01/2017 Labeler - Scientific Solutions Global, LLC (097291290) Establishment Name Address ID/FEI Business Operations Scientific Solutions Global, LLC 097291290 manufacture(71718-333)
