NUMB GEL ANESTHETIC- lidocaine hcl gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)
Available from:
RENU LABORATORIES, INC.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
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
Authorization status:
OTC monograph not final
Authorization number:
76348-595-01, 76348-595-02

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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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:76 348 -59 5

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LIDO CAINE HYDRO CHLO RIDE (UNII: V130 0 7Z41A) (LIDOCAINE -

UNII:9 8 PI20 0 9 8 7)

LIDOCAINE HYDROCHLORIDE

ANHYDROUS

1.12 g

in 28 g

Inactive Ingredients

Ingredient Name

Stre ng th

GLYCERIN (UNII: PDC6 A3C0 OX)

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

WATER (UNII: 0 59 QF0 KO0 R)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:76 348 -59 5-0 2

1 in 1 BOX

11/20 /20 20

1

NDC:76 348 -59 5-0 1

28 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

11/20 /20 20

Labeler -

RENU LABORAT ORIES, INC. (945739449)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

RENU LABORATORIES, INC.

9 45739 449

ma nufa c ture (76 348 -59 5)

Revised: 12/2020

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