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Biotemper by Biotemper

Medically reviewed on July 2, 2018

Dosage form: liquid
Ingredients: MENTHOL 10g in 100mL, CAMPHOR (SYNTHETIC) 2g in 100mL
Labeler: Biotemper
NDC Code: 70744-516

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 - Herbal Pain Relief Therapy

Drug Facts 

Active Ingredients

Menthol USP 10%.

Camphor USP 2%

Purpose

Topical Analgesic

Keep out of the reach of children: If ingested, seek medical help and contact a Poison Control Center immediately.

Uses : Soothing temporary relief from minor aches and pains associated with • sore muscles • strains • joint discomfort • arthritis • backache • tendonitis

Warning: For external use only.

Flammable: Keep away from excessive heat or open flames.

Ask a doctor before using if you have: Sensitive skin If pregnant or breast feeding: Ask a health professional before use.

When using this product: • Avoid contact with eyes or mucous membrane. • Do not apply to wounds or damaged skin. • Do not use with other ointments, creams, sprays or liniments. • Do not apply to irritated skin or if excessive irritation develops. • Do not bandage. • Wash hands after use with cool water • Do not use with heating pad or device.
Stop use and ask a doctor if: Condition worsens or if symptoms persist for more than 7 days or clear up and reoccur.

Directions: Adult and Children 2 years age and older: Rub a thin film over affected areas not more than 4 times daily: Massage not necessary Children under 2 years of age: Consult physician.

Inactive Ingredients: Aloe Vera Oil, Arnica Flower Tincture, Hydroxypropyl Cellulose NF, Isopropyl Alcohol, Propylene Glycol USP

Other information: Store in a cool and dry place with the lid closed tightly.

NO NSAIDS, IBUPROFEN, ASPIRIN OR SALICYLATE

FOR ARTHRITIS/BACK PAIN/ BRUISES/SORE MUSCLES/ SPORTS SPRAINS

Shake well before each use. Apply by rolling in only one direction.

Do not use in a circular motion

Packaging

BIOTEMPER 
menthol, camphor liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70744-516
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL10 g  in 100 mL
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ARNICA MONTANA FLOWER 
HYDROXYPROPYL CELLULOSE (TYPE E) 
ISOPROPYL ALCOHOL 
PROPYLENE GLYCOL 
Packaging
#Item CodePackage Description
1NDC:70744-516-0189 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/01/2016
Labeler - Biotemper (080260740)
Establishment
NameAddressID/FEIOperations
Pharmacena Labs, LLC075596057manufacture(70744-516)

 
Biotemper

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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