LIDOCREAM 5- lidocaine cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Golden Touch LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Topical Anesthetic For the temporary relief of pain and itching due to anorectal disorders

Authorization status:

OTC monograph final

Summary of Product characteristics

LIDOCREAM 5- LIDOCAINE CREAM
GOLDEN TOUCH LLC
_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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LIDOCREAM 5
_ACTIVE INGREDIENT_
Lidocaine 5% W/W
PURPOS E
Topical Anesthetic
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
contact a Poison Control Center right
away.
_USES_
For the temporary relief of pain and itching due to anorectal
disorders
_WARNINGS_
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT
Avoid contact with the eyes
Do not put in rectum
Do not exceed recommended dosage unless directed by a doctor
STOP USE AND ASK A DOCTOR IF
allergic reaction occurs
condition worsens or does not improve within 7 days
Symptoms clear up and return within a few days
rectal bleeding occurs
redness irritation, swelling, pain or other symptoms develop or
increase
DIRECTIONS
Adults when practical, cleanse the affected area with mild soap and
warm water and rinse thoroughly
Gently dry by patting or blotting with toilet tissue or a soft cloth
before application of this product
Apply externally to the affected area up to 6 times daily.
Children under 12 years of age: consult a doctor
_INACTIVE INGREDIENTS_
Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Carbomer, Disodium
EDTA, Glycerin, Glyceryl
Monooleate, SD Alcohol 40-B, Simmondsia Chinensis (Jojoba) Seed Oil,
Water
PACKAGING
LIDOCREAM 5
lidocaine cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:5276 3-50 1
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
LIDO CAINE (UNII: 9 8 PI20 0 9 8 7) (LIDOCAINE - UNII:9 8 PI20 0 9 8
7)
LIDOCAINE
5 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)
BENZYL ALCO HO L (UNII: LKG8 49 4WBH)
CARBO MER HO MO PO LYMER TYPE C ( ALLYL PENTAERYTHRITO L CRO SSLINKED)
(UNII: 4Q9 3RCW27E)
EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)
GLYCER