Capzix Cream

Capzix Cream
SPL v5
SPL
SPL Set ID a4555840-cf8f-45d8-90bb-3581102b58a7
Route
TOPICAL
Published
Effective Date 2019-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.001 g)
Inactive Ingredients
Water Cetyl Alcohol Petrolatum Glyceryl Monostearate Peg-100 Monostearate Sorbitol Isopropyl Myristate Benzyl Alcohol Citric Acid Monohydrate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-19

Description

Active Ingredient: Capsaicin 0.1%


Medication Information

Warnings and Precautions

Warnings:For external use only. Avoid contact with eyes.

Do notapply to wounds or damaged skin. Do notbandage tightly or apply local heat (such as heating pads) to the area of use. Stop use and ask  doctor ifcondition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Discontinue use.

Indications and Usage

Uses: Provides penetrating pain relief. Temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Dosage and Administration

Directions – Adults and children over 18

Apply to affected area not more than 3 to 4 times daily.

If product comes in contact with hands, wash with soap and water.

For children under 18 years of age ask a doctor.

Description

Active Ingredient: Capsaicin 0.1%

Section 42229-5

High Potency Pain Relief

For Arthritis, Sore Muscles, Joint and Back Pain Relief

NDC# 72847-316-20

Distributed by: TopRail Medical Products   Glencoe, IL   www.toprailmedical.com   Made in the USA

Section 44425-7

Other Information:STORE TIGHTLY CLOSED, IN A COOL DRY PLACE

Section 50565-1

Keep out of reach of children.If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive Ingredients: Water, Cetyl Alcohol, Petrolatum, Glyceryl Stearate, PEG-100 Stearate, Sorbitol, Isopropyl Myristate, Benzyl Alcohol, Citric Acid.

Section 55105-1

Purpose: Topical Analgesic

Section 55106-9

Active Ingredient: Capsaicin 0.1%

Packaging


Structured Label Content

Indications and Usage (34067-9)

Uses: Provides penetrating pain relief. Temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Dosage and Administration (34068-7)

Directions – Adults and children over 18

Apply to affected area not more than 3 to 4 times daily.

If product comes in contact with hands, wash with soap and water.

For children under 18 years of age ask a doctor.

Warnings and Precautions (34071-1)

Warnings:For external use only. Avoid contact with eyes.

Do notapply to wounds or damaged skin. Do notbandage tightly or apply local heat (such as heating pads) to the area of use. Stop use and ask  doctor ifcondition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Discontinue use.

Section 42229-5 (42229-5)

High Potency Pain Relief

For Arthritis, Sore Muscles, Joint and Back Pain Relief

NDC# 72847-316-20

Distributed by: TopRail Medical Products   Glencoe, IL   www.toprailmedical.com   Made in the USA

Section 44425-7 (44425-7)

Other Information:STORE TIGHTLY CLOSED, IN A COOL DRY PLACE

Section 50565-1 (50565-1)

Keep out of reach of children.If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive Ingredients: Water, Cetyl Alcohol, Petrolatum, Glyceryl Stearate, PEG-100 Stearate, Sorbitol, Isopropyl Myristate, Benzyl Alcohol, Citric Acid.

Section 55105-1 (55105-1)

Purpose: Topical Analgesic

Section 55106-9 (55106-9)

Active Ingredient: Capsaicin 0.1%

Packaging


Advanced Ingredient Data


Raw Label Data

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