Lansinoh Pain Relieving Spray

Lansinoh Pain Relieving Spray
SPL v8
SPL
SPL Set ID b7cf1fdb-946d-a4e8-e053-2995a90a26a8
Route
TOPICAL
Published
Effective Date 2021-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Aloe Vera Whole Peg-40 Castor Oil Eugenol Alcohol Witch Hazel Water Sodium Benzoate Poloxamer 188 Potassium Sorbate Almond Oil Peppermint Oil Carboxymethylcellulose Sodium (0.7 Carboxymethyl Substitution Per Saccharide; 2300 Mpa.s At 1%) Lavender Oil Phytate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-15

Description

Active Ingredient Purpose Lidocaine 4% Topical Analgesic


Medication Information

Warnings and Precautions

FOR EXTERNAL USE ONLY

Indications and Usage

For external use only

Dosage and Administration

Directions ■ For adult use only

■ Apply externally to the affected area not more than 3 - 4 times in a 24 hour period.

Description

Active Ingredient Purpose Lidocaine 4% Topical Analgesic

Section 50566-9

Stop use and ask a doctor if

■ Condition worsens

■ Symptoms persist for more than 7 days

■ Symptoms clear up and return within a

few days

Section 51727-6

Inactive Ingredients:

Alcohol (Ethanol), Aloe Barbadensis Leaf Juice, Cellulose Gum, Eugenol, Hamamelis Virginiana (Witch Hazel) Water, Lavandula Angustifolia (Lavender) Oil, Mentha Piperita (Peppermint) Oil, PEG-40 Hydrogenated Castor Oil, Poloxamer 188, Potassium Sorbate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sodium Benzoate, Sodium Phytate, Water.

Distributed By: Lansinoh Laboratories, Inc

Alexandria, VA 22314, USA

Tel: +1-800-292-4794 | www.lansinoh.com

Section 51945-4

Section 55105-1

Topical Analgesic

Warnings



Warnings

For external use only.

Do NOT use on breasts, nipples, in or

near mouth.

KEEP OUT OF REACH OF CHILDREN. Do

not use on infants or children under 12.

If swallowed, get medical help or contact

a Poison Control Center right away.

Drug Facts
Active Ingredient Purpose
Lidocaine 4% Topical Analgesic

Stop Use and Ask A Doctor

Stop use and ask a doctor if

■ Condition worsens

■ Symptoms persist for more than 7 days

■ Symptoms clear up and return within a

few day

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN. Do

not use on infants or children under 12.


Structured Label Content

Indications and Usage (34067-9)

For external use only

Dosage and Administration (34068-7)

Directions ■ For adult use only

■ Apply externally to the affected area not more than 3 - 4 times in a 24 hour period.

Warnings and Precautions (34071-1)

FOR EXTERNAL USE ONLY

Section 50566-9 (50566-9)

Stop use and ask a doctor if

■ Condition worsens

■ Symptoms persist for more than 7 days

■ Symptoms clear up and return within a

few days

Section 51727-6 (51727-6)

Inactive Ingredients:

Alcohol (Ethanol), Aloe Barbadensis Leaf Juice, Cellulose Gum, Eugenol, Hamamelis Virginiana (Witch Hazel) Water, Lavandula Angustifolia (Lavender) Oil, Mentha Piperita (Peppermint) Oil, PEG-40 Hydrogenated Castor Oil, Poloxamer 188, Potassium Sorbate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sodium Benzoate, Sodium Phytate, Water.

Distributed By: Lansinoh Laboratories, Inc

Alexandria, VA 22314, USA

Tel: +1-800-292-4794 | www.lansinoh.com

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical Analgesic

Warnings (WARNINGS)



Warnings

For external use only.

Do NOT use on breasts, nipples, in or

near mouth.

KEEP OUT OF REACH OF CHILDREN. Do

not use on infants or children under 12.

If swallowed, get medical help or contact

a Poison Control Center right away.

Drug Facts (DRUG FACTS)
Active Ingredient Purpose
Lidocaine 4% Topical Analgesic

Stop Use and Ask A Doctor (STOP USE AND ASK A DOCTOR)

Stop use and ask a doctor if

■ Condition worsens

■ Symptoms persist for more than 7 days

■ Symptoms clear up and return within a

few day

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

KEEP OUT OF REACH OF CHILDREN. Do

not use on infants or children under 12.


Advanced Ingredient Data


Raw Label Data

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