BIOEASE PAIN RELIEVING COLD THERAPY - menthol, camphor gel 
AHC Ventures Corp DBA Cryoderm

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BIOEASE® Pain Relieving Cold Therapy Roll-On

Active ingredient

Menthol USP……..3.5%
Camphor………….0.2%

Purpose

Pain Relief

Uses

Temporarily relieves minor aches and pains associated with • sore muscles and stiff joints • back pain • arthritis

Warnings

For external use only

When using this product: Use only as directed • Do not bandage or use a heating pad or device • Avoid contact with eyes and mucous membranes • Do not apply to open wounds or damaged skin • Do not use with other ointments, creams, sprays or liniments • After applying wash hands thoroughly with cool water

Stop use and ask a doctor if: Condition worsens or symptoms persist for more than 7 days or clear up and recur • Redness is present or irritation develops

Pregnancy or Breast Feeding

Ask a health professional before use

Keep Out of Reach of Children

In case of accidental ingestion get medical help or contact a Poison Control Center immediately

Directions

Adults and children 2 years of age and older: Apply directly onto affected area without the need to rub, massage or bandage • Repeat as necessary but do not apply more than 4 times daily.

Children under 2 years of age: Consult a Physician

Storage and Handling

Store in a cool dry place with lid or cap closed tightly

Inactive Ingredients

Isopropanol, Ilex Paraguariensis, Carbomer, Triethanolamine, Methylparaben, Silicon Dioxide, Deionized Water, Propylene Glycol, Glycerin, FD&C Blue #1, FD&C Yellow #5

Package/Label Principal Display Panel

Bioease Label
BIOEASE PAIN RELIEVING COLD THERAPY 
menthol, camphor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68678-053
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.5 g  in 100 mL
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL).2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
TROLAMINE (UNII: 9O3K93S3TK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68678-053-0395 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only01/01/2014
Labeler - AHC Ventures Corp DBA Cryoderm (131871779)

Revised: 2/2014
Document Id: fb673a32-822e-4844-b740-0770300f5e82
Set id: 3ad3724b-898d-43cf-bc45-72795eb20b0a
Version: 2
Effective Time: 20140202
 
AHC Ventures Corp DBA Cryoderm