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BioTemper by Scientific Solutions Global Llc

Dosage form: liquid
Ingredients: MENTHOL, UNSPECIFIED FORM 10g in 100mL
Labeler: Scientific Solutions Global Llc
NDC Code: 71718-111

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.

BIOTEMPER

Drug Facts

Active Ingredient

Menthol 10%

Purpose

Topical Analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains• bruises • sprains

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 skin 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. If swallowed, get medical help or contact a Poison Control Center right away

Directions

• Adults and children 2 years of age and older: Apply to affected area not more than 4 times daily in one direction, not circular. • Children under 2 years of age, consult a physician • Massage not necessary • Shake well before use

Inactive Ingredients

Aloe Barbadensis Oil, Arnica Montana Flower Extract, Boswellia Carteri Powder, Camphor, Camellia Oleifera Oil, Hydroxypropyl Cellulose, Isopropyl Alcohol, Propylene Glycol, Melaleuca Alternifolia Oil, Thymol, Alpha-Tocopherol

Other Information

• store in a cool and dry place with the lid closed tightly

Questions or Comments?

Call us at: 1(516)543-3376 M-F 9am-6pm EST or E-mail:info@biotemper.com

FAST ACTING ROLL-ON

FOR ARTHRITIS, SPRAINS, SORE MUSCLES, BRUISES, & BACK PAIN

MADE WITH HERBAL & HOMEOPATHIC INGREDIENTS

NO NSAIDs, IBUPROFEN, ASPIRIN, OR SALICYLATE

BIOTEMPER.COM

DISTRIBUTED BY:

SCIENTIFIC SOLUTIONS GLOBAL, LLC

CARLE PLACE, NY

PROUDLY MADE IN USA

Packaging

BIOTEMPER 
menthol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71718-111
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (MENTHOL) MENTHOL, UNSPECIFIED FORM10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ARNICA MONTANA FLOWER 
FRANKINCENSE OIL 
CAMPHOR (SYNTHETIC) 
CAMELLIA OIL 
HYDROXYPROPYL CELLULOSE, UNSPECIFIED 
ISOPROPYL ALCOHOL 
PROPYLENE GLYCOL 
TEA TREE OIL 
THYMOL 
.ALPHA.-TOCOPHEROL 
Packaging
#Item CodePackage Description
1NDC:71718-111-0189 mL in 1 BOTTLE
2NDC:71718-111-022 BOTTLE in 1 PACKAGE
289 mL in 1 BOTTLE
3NDC:71718-111-033 BOTTLE in 1 PACKAGE
389 mL in 1 BOTTLE
4NDC:71718-111-044 BOTTLE in 1 PACKAGE
489 mL in 1 BOTTLE
5NDC:71718-111-056 BOTTLE in 1 PACKAGE
589 mL in 1 BOTTLE
6NDC:71718-111-0612 BOTTLE in 1 PACKAGE
689 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/03/2017
Labeler - Scientific Solutions Global Llc (097291290)
Establishment
NameAddressID/FEIOperations
Scientific Solutions Global Llc097291290manufacture(71718-111)

Revised: 08/2017
 
Scientific Solutions Global Llc

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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