Drug Facts

Active Ingredients

Menthol 10.00%

Methyl Salicylate 10.00%

Histamine DHCl 0.050%

Purpose

Topical Analgesic

Uses:

For the temporary relief of minor aches and pains of the muscles and joints associated with arhritis, simple backache, sprains, bruises and strains.

Warnings:

For External use only
Keep out of reach of children. If swallowed, consult physician.
Do not apply to wounds or damaged skin.

When using this product

Avoid contact with eyes. If product gets into eyes, rinse thoroughly with water
Do not bandage tightly

Stop use and ask a doctor if:

Rash appears
If symptoms persist for more than seven days, discontinue use and consult physician

If pregnant or breastfeeding,

ask a healthcare professional before use.

Keep out of reach of children.

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

Directions

Apply to affected area 3-4 times daily. Adults and children two-years of age or older:
Consult a physician Children under two-years of age:

Other Information

Store at room temperature with lid closed tightly.

Other Ingredients

Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Extract, AScorbic Acid (Vitamin C), Bosewellia Serrata Extract, Bromelain, Butylene Glycol, C13-14 Isoparaffin, Chamomilla Recutta (Chamomile) Extract, Citric Acid, Curcuma Longa (Turmeric) Extract, Emu Oil, Ethylhexylglycerin, Ethylhexyl Stearate, Glycyrrhiza Glabra (licorice) Root Extract, Helianthus Annuus (Sunflower) Oil, Laureth-7, magnesium Sulfate, Methylsulfonylmethane (MSM), Niacin, Phenoxyethanol, Polyacrylamide, Polysorbate-80, Potassium Sorbate, Sodium Polyacrylate, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Tricedeth-6, Zingiber Officinale (Ginger) Root Extract

Questions or Comments?

(support email address) or Call 1.855.977.0726

Package Labeling:

Label

TERRAFREEZE PAIN RELIEF
menthol,methyl salicylate,histamine dihydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71805-855
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	100 mg in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	100 mg in 1 g
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	0.5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA (UNII: O80TY208ZW)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
BROMELAINS (UNII: U182GP2CF3)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TURMERIC (UNII: 856YO1Z64F)
EMU OIL (UNII: 344821WD61)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
LICORICE (UNII: 61ZBX54883)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LAURETH-7 (UNII: Z95S6G8201)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
NIACIN (UNII: 2679MF687A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
GINGER (UNII: C5529G5JPQ)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71805-855-00	1 in 1 BOX	10/12/2017
1		57 g in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	10/12/2017

Labeler - Beyond Derma, LLC (080699834)

TerraFreeze Pain Relief Cream