SPL v6
SPL
SPL Set ID bd9d0bc0-5705-4c73-bcd6-f6cdb68e05b6
Route
TOPICAL
Published
Effective Date 2019-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (10 g) Menthol (3 g)
Inactive Ingredients
Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Aloe Vera Leaf Water Cetyl Alcohol Diazolidinyl Urea Isopropyl Myristate Methylparaben Polyethylene Glycol 400 Propylparaben Propylene Glycol Sodium Lauryl Sulfate Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-01-15

Description

Drugs Facts

Purpose

Topical Analgesic Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Topical Analgesic

Description

Drugs Facts

Uses

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

Section 42229-5

Drugs Facts

Section 50565-1

Keep out of reach of children. If swallowed, consult physician.

If pregnant or breast feeding, contact physician prior to use.

Warning

For external use only.

Avoid contact with eyes and mucous membranes.

Do not bandage tightly or cover treated areas.

Do not use with heating pad.

Do not 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.

Directions

For adults apply directly to affected area. Repeat as necessary, but do not use more than 3-4 times daily.

Other Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Diazolidinyl Urea, Isopropyl Myristate, Methyl Paraben, PEG-8, Propyl Paraben, Propylene Glycol, Sodium lauryl Sulfate, Triethanolamine.

Active Ingredients

Methyl Salicylate………10.00%

Menthol…………………3.00%

Additional Information

Store at room temperature.

Principal Display Panel

NDC 76420-450-12

Calypxo

Pain Relief Cream

4 oz (113g)

Distributed by:

Enovachem

PHARMACEUTICALS

Torrance, CA 90501

(310) 320-0100


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drugs Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, consult physician.

If pregnant or breast feeding, contact physician prior to use.

Purpose

Topical Analgesic

Topical Analgesic

Warning

For external use only.

Avoid contact with eyes and mucous membranes.

Do not bandage tightly or cover treated areas.

Do not use with heating pad.

Do not 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.

Directions

For adults apply directly to affected area. Repeat as necessary, but do not use more than 3-4 times daily.

Other Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Diazolidinyl Urea, Isopropyl Myristate, Methyl Paraben, PEG-8, Propyl Paraben, Propylene Glycol, Sodium lauryl Sulfate, Triethanolamine.

Active Ingredients

Methyl Salicylate………10.00%

Menthol…………………3.00%

Additional Information

Store at room temperature.

Principal Display Panel

NDC 76420-450-12

Calypxo

Pain Relief Cream

4 oz (113g)

Distributed by:

Enovachem

PHARMACEUTICALS

Torrance, CA 90501

(310) 320-0100


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)