CALYPXO HP PAIN RELIEF- methyl salicylate, menthol cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Available from:

Asclemed USA, Inc

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Topical Analgesic Topical Analgesic For temporary relief of minor aches and pains associated with simple backaches, arthritis, bruises, sprains and cramps.

Authorization status:

OTC monograph not final

Summary of Product characteristics

CALYPXO HP PAIN RELIEF- METHYL SALICYLATE, MENTHOL CREAM
ASCLEMED USA, INC
----------
DRUGS FACTS
ACTIVE INGREDIENTS
Methyl Salicylate………15.00%
Menthol……………………10.00%
PURPOSE
Topical Analgesic
Topical Analgesic
USES
For temporary relief of minor aches and pains associated with simple
backaches,
arthritis, bruises, sprains and cramps.
WARNING
For external use only.
Avoid contact with eyes and mucous membranes.
Do not
bandage tightly or cover treated areas.
use with heating pad.
apply to open wounds or damages skin.
A mild burning sensation may occur.
If severe burning sensation occurs, discontinue use immediately.
If symptoms persist for more than seven days, discontinue use and
consult
physician.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, consult physician.
If pregnant or breast feeding, contact physician prior to use.
DIRECTIONS
For adults apply directly to affected area. Repeat as necessary, but
do not use more
than 3-4 times daily.
ADDITIONAL INFORMATION
Store at room temperature.
OTHER INGREDIENTS
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf
(Aloe Vera Gel)
Juice, Aqua (Deionized Water), Cetyl Alcohol, Ethylhexylglycerin,
Isopropyl Myristate,
PEG-8, Phenoxyethanol, Sodium Lauryl Sulfate, Triethanolamine.
PRINCIPAL DISPLAY PANEL
NDC 76420-999-01
CALYPXO HP
PAIN RELIEF CREAM
4 oz (113g)
Distributed by:
ENOVACHEM
PHARMACEUTICALS
TORRANCE, CA 90501
[phone]
Asclemed USA, Inc
CALYPXO HP PAIN RELIEF
methyl salicylate, menthol cream
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:76420-999
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID -
UNII:O414PZ4LPZ)
METHYL SALICYLATE
15 g in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
MENTHOL
10 g in 100 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII:
59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059Q