LIDOCREAM 10- 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 Uses For the temporary relief of pain and itching due to anorectal disorders

Authorization status:

OTC monograph final

Summary of Product characteristics

LIDOCREAM 10- 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 10
_DRUG FACTS_
_ACTIVE INGREDIENT_
Lidocaine 10% w/w
_PURPOSE_
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 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 upto 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 10
lidocaine cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:5276 3-10 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
10 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)
(U