RECOVERY NUMBING- lidocaine hcl spray 
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.

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RECOVERY NUMBING SPRAY

Active Ingredients

Lidocaine HCl 5 %

Purpose

Topical Anesthetic

USES: Temporarily relieves pain, itching and burning associated with inflamed hemorrhoidal tissues.

WARNINGS: FOR EXTERNAL USE ONLY

Stop and ask a doctor if an allergic reaction or rectal bleeding occurs; redness, irritation, swelling, pain or other symptoms begin or increase; condition worsens or does not improve within 7 days.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use.

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

DIRECTIONS:

Adults and children 12 years and older: When practical, clean area with mild soap and warm water and rinse thoroughly. Gently pat or blot dry with a clean tissue or soft cloth before applying. Apply to the affected area up to 6 times a day.

Children under 12 years of age: Consult a doctor.

Other information: Store between 14C - 25C (58F - 77F). Avoid freezing, excessive heat or direct sunlight.

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

RECOVERY

NUMBING SPRAY

FAST-ACTING TOPICAL

ANESTHETIC WITH ALOE

NET WT 4 FL OZ (118 mL)

NDC 76348-585-04

When using this product avoid contact with eyes

Rinse with water to remove

Do not use in large quantities particularl over raw skin or blistered areas

PRODUCT LABEL

product label

RECOVERY NUMBING 
lidocaine hcl spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-980
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5.9 g  in 118 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76348-980-04118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01508/01/2022
Labeler - Renu Laboratories, Inc. (945739449)
Establishment
NameAddressID/FEIBusiness Operations
Renu Laboratories, Inc.945739449manufacture(76348-980)

Revised: 8/2022
Document Id: e4e05cae-56a7-b2b3-e053-2a95a90a104b
Set id: e4e05cae-56a6-b2b3-e053-2a95a90a104b
Version: 1
Effective Time: 20220801
 
Renu Laboratories, Inc.