LANSINOH PAIN RELIEVING- lidocaine hcl spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)

Available from:

Lansinoh Laboratories Inc

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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 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 For external use only Topical Analgesic

Authorization status:

OTC monograph not final

Summary of Product characteristics

LANSINOH PAIN RELIEVING- LIDOCAINE HCL SPRAY
LANSINOH LABORATORIES INC
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may_
_be marketed if they comply with applicable regulations and policies.
FDA has not_
_evaluated whether this product complies._
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LANSINOH PAIN RELIEVING SPRAY
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.
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.
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
Directions ■ For adult use only
■ Apply externally to the affected area not more than 3 - 4 times in
a 24 hour period.
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: [phone] | www.lansinoh.com
FOR EXTERNAL USE ONLY
For external use only
Topical Analgesic
LANSINOH PAIN RELIEVING
lidocaine hcl spray
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:53997-001
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)
LIDOCAINE
4 g in 100 mL
INACTIVE INGREDIENTS
INGREDI