ZAXS ACHES AND PAIN- capsicum, methyl salicylate, menthol cream

Zaxs Aches and Pain by

Drug Labeling and Warnings

Zaxs Aches and Pain by is a Otc medication manufactured, distributed, or labeled by Canadian Custom Packaging Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Capsicum 0.13%

Methyl Salicylate 10.5%

Menthol 5%

PURPOSE

Topical Analgesic

INDICATIONS & USAGE

For the temporary relief of minor aches and pains of muscles and joints associated with: Simple backache, Arthritis, Strains, Bruises, Sprains. Penetrating pain relief.

DOSAGE & ADMINISTRATION

For use by Adults and Children over 12 years of age: Apply a thin layer to affected area, not more than 4 times a day. Rub and massage into skin until solution vanishes. Always wash hands after applying. Store in airtight, light resistant container at room temperature.

WARNINGS

For external use only.

Allergy alert: If allergic to aspirin or salicylates, consult a physician before use.

When using this product, use only as directed. Make sure you understand directions and warnings on label before use.

°Rare case of burns have been reported with products of this type.

°Do not apply with external heat (such as electric heating pad) or bandage tightly.

°Do not apply to wounds or damaged skin, or irritated skin.

°If you are allergic to any ingredient in this product, do not use. Avoid contact with eyes and mucous membranes.

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

Stop use if: Redness is present, irritation develops, you experience pain, swelling or blistering where product is applied.

Consult a physician if you are breastfeeding or pregnant before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, consult a Poison Control Centre immediately.

INACTIVE INGREDIENT

Aqua, Butyrospermum Parkii (Shea Butter) Extraxt, Caprylic/capric triglyceride, Caprylyl Glycol, Camphor, Carbomer copolymer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Eucalyptus Leaf Oil, Glycerin, Mentha piperita (Peppermint) oil, Phenoxyethanol, Polysorbate 20, Sodium Hydroxide, Sorbic acid, Xanthan Gum

PRINCIPAL DISPLAY PANEL

Tube Label

INGREDIENTS AND APPEARANCE

ZAXS ACHES AND PAIN 
capsicum, methyl salicylate, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54291-054
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG)	CAPSICUM	1.3 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	50 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	105 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
EUCALYPTUS OIL (UNII: 2R04ONI662)
PEPPERMINT OIL (UNII: AV092KU4JH)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBIC ACID (UNII: X045WJ989B)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54291-054-01	120 g in 1 TUBE; Type 0: Not a Combination Product	11/22/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	11/22/2021

Labeler - Canadian Custom Packaging Company (207062514)

Registrant - Canadian Custom Packaging Company (207062514)

Establishment
Name	Address	ID/FEI	Business Operations
Canadian Custom Packaging Company		207062514	manufacture(54291-054)