País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)
RENU LABORATORIES, INC.
TOPICAL
OTC DRUG
Topical anesthetic Uses: For temporary relief of pain associated with minor skin procedures 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 - redness, irritation, swelling, pain or other symptoms begin or increase
OTC monograph not final
NUMB GEL ANESTHETIC- LIDOCAINE HCL GEL RENU 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._ ---------- NUMB GEL ANESTHETIC Lidocaine HCl 4% Topical anesthetic USES: For temporary relief of pain associated with minor skin procedures For External Use only. WHEN USING THIS PRODUCT, do not use in or near the eyes • do not use in large quantities, particularly over raw surfaces or blistered areas. • do not use on puncture wounds • for more than one week without consulting 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 redness, irritation, swelling, pain or other symptoms begin or increase KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS: ADULTS AND CHILDREN 2 YEARS AND OLDER: apply to the affected area up to 3 to 4 times a day CHILDREN UNDER 2 YEARS - ask a doctor INACTIVE INGREDIENTS: Aloe Barbadensis Leaf Powder, Benzyl Alcohol, Deionized Water, Disodium EDTA, Ethyl Alcohol SD 40B, Glycerin Store at 20 - 25 C (68 - 77 degrees F) QUESTIONS? 574-975-3632 If pregnant or breast-feeding, ask a health professional before use. JAR LABEL AND BOX ART RENU LABORATORIES, INC. NUMB GEL ANESTHETIC lidocaine hcl gel PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:76348-595 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 1.12 g in 28 g INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH GLYCERIN (UNII: PDC6A3C0OX) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ALOE VERA LEAF (UNII: ZY81Z83H0X) BENZYL ALCOHOL (UNII: LKG8494WBH) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) PACKAGI Leer el documento completo