Label: BIOTEMPER- menthol gel
BIOTEMPER FOOT CREAM- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 81376-001-01, 81376-001-02, 81376-001-03, 81376-001-04, view more81376-001-05, 81376-001-06, 81376-002-01 - Packager: SSG Ventures Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated April 21, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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PRINCIPAL DISPLAY PANEL
KEEP OUT OF REACH OF CHILDREN.
IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY
Adults & children 2 yrs of age and older: Apply to affected area not more than 4 times daily. Children under 2 years of age, consult a physician. Massage not necessary. Shake well before use.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BIOTEMPER
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81376-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g in 10 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ARNICA MONTANA (UNII: O80TY208ZW) THYMOL (UNII: 3J50XA376E) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAMPHOR (NATURAL) (UNII: N20HL7Q941) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) ISOPROPYL ALCOHOL (UNII: ND2M416302) TEA TREE OIL (UNII: VIF565UC2G) BOSWELLIA SACRA BARK (UNII: 1UK28DX728) FRANKINCENSE OIL (UNII: 67ZYA5T02K) GREEN TEA LEAF (UNII: W2ZU1RY8B0) LAVENDER OIL (UNII: ZBP1YXW0H8) Product Characteristics Color white (Opaque) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81376-001-01 113 mL in 1 JAR; Type 0: Not a Combination Product 01/01/2021 2 NDC:81376-001-02 452 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/01/2021 3 NDC:81376-001-03 1900 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/01/2021 4 NDC:81376-001-04 89 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 01/01/2021 5 NDC:81376-001-05 118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/01/2021 6 NDC:81376-001-06 118 mL in 1 TUBE; Type 0: Not a Combination Product 01/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2021 BIOTEMPER FOOT CREAM
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81376-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g in 10 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ARNICA MONTANA (UNII: O80TY208ZW) THYMOL (UNII: 3J50XA376E) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAMPHOR (NATURAL) (UNII: N20HL7Q941) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) ISOPROPYL ALCOHOL (UNII: ND2M416302) TEA TREE OIL (UNII: VIF565UC2G) BOSWELLIA SACRA BARK (UNII: 1UK28DX728) FRANKINCENSE OIL (UNII: 67ZYA5T02K) GREEN TEA LEAF (UNII: W2ZU1RY8B0) LAVENDER OIL (UNII: ZBP1YXW0H8) WATER (UNII: 059QF0KO0R) POLYSORBATE 60 (UNII: CAL22UVI4M) Product Characteristics Color white (Opaque) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81376-002-01 57 mL in 1 JAR; Type 0: Not a Combination Product 01/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2021 Labeler - SSG Ventures Inc (047626115) Establishment Name Address ID/FEI Business Operations SSG Ventures Inc 047626115 manufacture(81376-001, 81376-002)
