X-TREME FREEZE- cold therapy gel gel

X-Treme Freeze by

Drug Labeling and Warnings

X-Treme Freeze by is a Otc medication manufactured, distributed, or labeled by Dynarex Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Menthol USP 4% Active

Purpose

Cooling Pain Relief

Use

Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis, backache, strains, sprains.

Warnings

For external use only

Flammable:

Keep away from excessive heat or open flame

Ask a doctor before use if you have:

sensitive skin

When using this product:

• Avoid contact with eyes or mucous membranes
• 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
• symptoms last more than 7 days or clear up and occur again within a few days

If pregnant or breast feeding:

Ask a health professional before use.

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

Directions

• Adults and children 2 years of age or 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

Other Information

Store in a cool dry place

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Boswellia Certerii Resin Extract, Brilliant Blue, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract (Green Tea Leaf), Camphor, Carbomer, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis Leaf Extract, Purified Water, Silicon Dioxide, Tartrazine, Tocopheryl Acetate, Triethanolamine

Questions?

1-888-DYNAREX Monday-Friday, 9AM-5PM EST

Label 1441

Label 1442

Label 1444

Label 1447

INGREDIENTS AND APPEARANCE

X-TREME FREEZE 
cold therapy gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-144
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
FRANKINCENSE (UNII: R9XLF1R1WM)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.,.ALPHA.-DIBROMO-D-CAMPHOR (UNII: F89Z8SAG3O)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-144-10	200 in 1 CASE	08/17/2018
1		100 in 1 BOX
1		2.88 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 67777-144-20	24 in 1 CASE	08/17/2018
2		113.28 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 67777-144-40	12 in 1 CASE	08/17/2018
3		454 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
4	NDC: 67777-144-70	2 in 1 CASE	08/17/2018
4		3633.6 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/17/2018

Labeler - Dynarex Corporation (008124539)