A2a Capsaicin Cream

A2a Capsaicin Cream
SPL v3
SPL
SPL Set ID 147f3594-7362-7a78-e063-6294a90a3e42
Route
TOPICAL
Published
Effective Date 2024-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.1 g)
Inactive Ingredients
Water Peg-100 Stearate Propylene Glycol Cetyl Alcohol Peppermint Oil Phenoxyethanol Aloe Vera Leaf Mineral Oil Xanthan Gum White Petrolatum Glyceryl Stearate Se Stearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-25

Description

Capsaicin 0.1%


Medication Information

Warnings and Precautions



Warnings

For external use only

Read all warnings and directions before use. Test first on small area of skin.

Indications and Usage

Uses

Temporarily relieves minor aches and pains of muscles and joints due to

simple backache

arthritis

strains

sprains

Dosage and Administration

Adults and children 18 years of age and older:

apply a thin film of cream to affected area and gently tub in until fully absorbed

unless treating hands, wash hands thoroughly with soap and water immediately after application

for best results apply 3 to 4 times daily.

Children under 18 years: ask a doctor

Description

Capsaicin 0.1%

Section 44425-7

Other Information: Store at room temperature 15°- 30°C (59° - 86°F)

Section 50565-1

Keep out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

Section 50567-7

When using this product:

you may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. with regular use, this sensation generally disappears after several days

avoid contact with the eyes, lips, nose, and mucous membranes

do not tightly wrap or bandage the treated area

do not apply heat to the treated area immediately before or after use.

Section 50569-3

Ask Doctor

Stop use and ask a doctor if:

condition worsens or does not improve after regular use

severe burning persists or blistering occurs.

Section 50570-1

Do not use:

on wounds or damaged skin

if you are allergic to capsaicin or chili peppers

Section 51727-6

aloe barbadensis leaf extract, cetyl alcohol, glyceryl stearate SE, mineral oil, PEG-100 stearate, peppermint oil, phenoxyethanol, propylene glycol, purified water, stearyl alcohol, white petrolatum, xanthan gum.

Section 51945-4

Section 53413-1

Questions or comments?

Call (800) 380-6709

Distributed By:

A2A Integrated Pharmaceuticals

Franklin, KY 42134

Section 55105-1

External Analgesic

Section 55106-9

Capsaicin 0.1%


Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves minor aches and pains of muscles and joints due to

simple backache

arthritis

strains

sprains

Dosage and Administration (34068-7)

Adults and children 18 years of age and older:

apply a thin film of cream to affected area and gently tub in until fully absorbed

unless treating hands, wash hands thoroughly with soap and water immediately after application

for best results apply 3 to 4 times daily.

Children under 18 years: ask a doctor

Warnings and Precautions (34071-1)



Warnings

For external use only

Read all warnings and directions before use. Test first on small area of skin.

Section 44425-7 (44425-7)

Other Information: Store at room temperature 15°- 30°C (59° - 86°F)

Section 50565-1 (50565-1)

Keep out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

Section 50567-7 (50567-7)

When using this product:

you may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. with regular use, this sensation generally disappears after several days

avoid contact with the eyes, lips, nose, and mucous membranes

do not tightly wrap or bandage the treated area

do not apply heat to the treated area immediately before or after use.

Section 50569-3 (50569-3)

Ask Doctor

Stop use and ask a doctor if:

condition worsens or does not improve after regular use

severe burning persists or blistering occurs.

Section 50570-1 (50570-1)

Do not use:

on wounds or damaged skin

if you are allergic to capsaicin or chili peppers

Section 51727-6 (51727-6)

aloe barbadensis leaf extract, cetyl alcohol, glyceryl stearate SE, mineral oil, PEG-100 stearate, peppermint oil, phenoxyethanol, propylene glycol, purified water, stearyl alcohol, white petrolatum, xanthan gum.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Call (800) 380-6709

Distributed By:

A2A Integrated Pharmaceuticals

Franklin, KY 42134

Section 55105-1 (55105-1)

External Analgesic

Section 55106-9 (55106-9)

Capsaicin 0.1%


Advanced Ingredient Data


Raw Label Data

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