Country: United States
Language: English
Source: NLM (National Library of Medicine)
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)
Golden Touch LLC
TOPICAL
OTC DRUG
Topical Anesthetic For the temporary relief of pain and itching due to anorectal disorders
OTC monograph final
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._ ---------- 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 Read the complete document