BIOEASE PAIN RELIEVING COLD THERAPY- menthol, camphor gel

BIOEASE PAIN RELIEVING COLD THERAPY by

Drug Labeling and Warnings

BIOEASE PAIN RELIEVING COLD THERAPY by is a Otc medication manufactured, distributed, or labeled by AHC Ventures Corp DBA Cryoderm. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

BIOEASE PAIN RELIEVING COLD THERAPY 
menthol, camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68678-053
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.5 g  in 100 mL
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68678-053-03	95 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		01/01/2014

Labeler - AHC Ventures Corp DBA Cryoderm (131871779)