NUMB GEL ANESTHETIC- lidocaine hcl gel

Numb Gel Anesthetic by

Drug Labeling and Warnings

Numb Gel Anesthetic by is a Otc medication manufactured, distributed, or labeled by RENU LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine HCl 4%

PURPOSE

Topical anesthetic

INDICATIONS & USAGE

Uses: For temporary relief of pain associated with minor skin procedures

WARNINGS

For External Use only.

WHEN USING

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

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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 INGREDIENT

Inactive Ingredients: Aloe Barbadensis Leaf Powder, Benzyl Alcohol, Deionized Water, Disodium EDTA, Ethyl Alcohol SD 40B, Glycerin

OTHER SAFETY INFORMATION

Store at 20 - 25 C (68 - 77 degrees F)

QUESTIONS

Questions? 574-975-3632

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

PRINCIPAL DISPLAY PANEL

JAR LABEL AND BOX ART

INGREDIENTS AND APPEARANCE

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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-595-02	1 in 1 BOX	11/20/2020
1	NDC: 76348-595-01	28 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/20/2020

Labeler - RENU LABORATORIES, INC. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
RENU LABORATORIES, INC.		945739449	manufacture(76348-595)