Semprae Capsaicin 

Semprae Capsaicin 
SPL v1
SPL
SPL Set ID 5993d5ad-b949-4bb7-bc76-190477ed5df0
Route
TOPICAL
Published
Effective Date 2019-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (.075 g)
Inactive Ingredients
Almond Oil Arginine Hydrochloride Benzyl Alcohol Benzyl Benzoate Butylated Hydroxytoluene Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Citrulline Cinnamon Bark Oil Coriander Oil Edetate Disodium Isopropyl Alcohol Polyoxyl 40 Hydrogenated Castor Oil Propylene Glycol Sorbitol Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-12-10

Description

Capsaicin 0.075%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Capsaicin 0.075%

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

• simple backache

• arthritis

• strains

• bruises

• sprains

Warnings

For external use only

Directions

Adults and children over 18 years:

• Apply to affected area

• Massage into painful area until thoroughly absorbed

• Repeat as necessary, but no more than 3 to 4 times daily



Children 18 years or younger: ask a doctor

Neuriterx Carton

Active Ingredient

Capsaicin 0.075%

Other Information

Store at 20° - 25°C (68° - 77°F)

Do not use if inner container seal is damaged or missing.

Inactive Ingredients

Almond Oil, Benzyl Alcohol, Benzyl Benzoate, Butylated Hydroxytoluene, Carbomer Copolymer Type B, Cinnamon Bark Oil, Coriander Oil, Edetate Disodium, Isopropyl Alcohol, L-Arginine HCl, L-Citrulline , Polyoxl 40 Hydrogenated Castor Oil, Propylene Glycol, Sorbitol,Trolamine, Water

When Using This Product

• use only as directed

• do not bandage tightly

• do not use with heating pad

• avoid contact with eyes and mucous membranes

• do not apply to wounds, damaged, broken or irritated skin

• a transient burning sensation may occur upon application but generally disappears in several days

• if severe burning sensation occurs, discontinue use immediately

• do not expose the area treated with product to heat or direct sunlight

Stop Use and Ask A Doctor If

• Condition worsens

• Redness is present

• Irritation develops 

• Symptoms persist for more than 7 days or symptoms clear up and occur again within a few days

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

• simple backache

• arthritis

• strains

• bruises

• sprains

Purpose

Topical Analgesic

Warnings

For external use only

Directions

Adults and children over 18 years:

• Apply to affected area

• Massage into painful area until thoroughly absorbed

• Repeat as necessary, but no more than 3 to 4 times daily



Children 18 years or younger: ask a doctor

Neuriterx Carton

Active Ingredient

Capsaicin 0.075%

Other Information

Store at 20° - 25°C (68° - 77°F)

Do not use if inner container seal is damaged or missing.

Inactive Ingredients

Almond Oil, Benzyl Alcohol, Benzyl Benzoate, Butylated Hydroxytoluene, Carbomer Copolymer Type B, Cinnamon Bark Oil, Coriander Oil, Edetate Disodium, Isopropyl Alcohol, L-Arginine HCl, L-Citrulline , Polyoxl 40 Hydrogenated Castor Oil, Propylene Glycol, Sorbitol,Trolamine, Water

When Using This Product (When using this product)

• use only as directed

• do not bandage tightly

• do not use with heating pad

• avoid contact with eyes and mucous membranes

• do not apply to wounds, damaged, broken or irritated skin

• a transient burning sensation may occur upon application but generally disappears in several days

• if severe burning sensation occurs, discontinue use immediately

• do not expose the area treated with product to heat or direct sunlight

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• Condition worsens

• Redness is present

• Irritation develops 

• Symptoms persist for more than 7 days or symptoms clear up and occur again within a few days

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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