Active Ingredient

Menthol USP 4% Active

Purpose

Cooling Pain Relief

Use(s)

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

Keep out of reach of children

If swallowed, get medical help, contact a physician or Poison Control Center (1-800-222-1222) 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 befor use

Other Information

• Store in a cool dry place

• Tamper evident. Do not use if seal is damaged.

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, Llex 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

1441 Label

1441_BX_MASTER

1442 Label

1442_IN_MASTER

1444 Label

1444_IN_MASTER

1447 Label

1447_IN MASTER

X-TREME FREEZE
cold therapy gel gel

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

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

Ingredient Name	Strength
Inactive Ingredients
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:67777-144-10	200 in 1 CASE	08/17/2018
1	NDC:67777-144-11	100 in 1 BOX
1		3 mL in 1 PACKET; Type 0: Not a Combination Product
2	NDC:67777-144-20	24 in 1 CASE	08/17/2018
2	NDC:67777-144-21	118 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC:67777-144-40	12 in 1 CASE	08/17/2018
3	NDC:67777-144-41	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
4	NDC:67777-144-70	2 in 1 CASE	08/17/2018
4	NDC:67777-144-71	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

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

Labeler - Dynarex Corporation (008124539)

1441 Extreme Freeze NDC 67777-144-10 1442 Extreme Freeze NDC 67777-144-20 1444 Extreme Freeze NDC 67777-144-40 1447 Extreme Freeze NDC 67777-144-70