THERMAL-AID HEADACHE RELIEF- bryonia alba root and toxicodendron pubescens leaf cream

thermal-AID by

Drug Labeling and Warnings

thermal-AID by is a Homeopathic medication manufactured, distributed, or labeled by Pacific Shore Holdings, Inc., Filltech USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Bryonia 6x HPUS 0.1%	Muscle aches and stiffness
Rhus Toxicodendron 6x HPUS 0.1%	Muscle pain and stiffness

Uses

External analgesic for temporary relief of headache and migraine pain.

Warnings

For external use only. Avoid contact with eyes and open wounds.

Stop use and ask a doctor if condition persists for more than 7 days or worsens.

Keep out of reach of children. In case of ingestion, seek professional assistance or contact a poison control center.

Directions

Adults and children age 12 and older: Apply a small amount of cream to forehead and temples, and massage into skin. Use as needed and when headache pain flares up.

Other Information

Store at 68 to 77 degrees Fahrenheit.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Steric Acid, Polysorbate 60, Cocos Nucifera (Coconut) Oil, Cetyl Alcohol, Cetearyl Alcohol, Propylene Glycol, Mineral Oil, Myristyl Myristate, Glycine Soja (Soybean) Oil, Sodium Chloride, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Menthol, Tocopheryl Acetate, Squalene, Soluble Collagen, Hydrolyzed Elastin, Allium Sativum (Garlic) Bulb Extract, Glycerin, Caprylhydroxamic Acid, Benzyl Alcohol.

SPL UNCLASSIFIED SECTION

Distributed by:
Pacific Shore Holdings, Inc.
Chatsworth, CA 91311

PRINCIPAL DISPLAY PANEL - 57 g Tube Label

thermal-AID®

Headache Relief Cream
Fast, Safe, Powerful Relief You Can Count On

NET WT 2 OZ. (57g)

INGREDIENTS AND APPEARANCE

THERMAL-AID   HEADACHE RELIEF
bryonia alba root and toxicodendron pubescens leaf cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69314-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	6 [hp_X]  in 57 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	6 [hp_X]  in 57 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYSORBATE 60 (UNII: CAL22UVI4M)
COCONUT OIL (UNII: Q9L0O73W7L)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MINERAL OIL (UNII: T5L8T28FGP)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
SOYBEAN OIL (UNII: 241ATL177A)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALMOND OIL (UNII: 66YXD4DKO9)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SQUALENE (UNII: 7QWM220FJH)
HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW) (UNII: ZR28QKN0WT)
GARLIC (UNII: V1V998DC17)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BOVINE TYPE I COLLAGEN (UNII: FHJ3ATL51C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69314-201-42	57 g in 1 TUBE; Type 0: Not a Combination Product	08/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		08/01/2019

Labeler - Pacific Shore Holdings, Inc. (809755148)

Establishment
Name	Address	ID/FEI	Business Operations
Filltech USA, LLC		926433855	MANUFACTURE(69314-201)