RECOVERY NUMBING- lidocaine hcl spray

RECOVERY Numbing by

Drug Labeling and Warnings

RECOVERY Numbing by is a Otc medication manufactured, distributed, or labeled by Renu Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Lidocaine HCl 5 %

PURPOSE

Purpose

Topical Anesthetic

INDICATIONS & USAGE

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

WARNINGS

WARNINGS: FOR EXTERNAL USE ONLY

STOP USE

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

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 SAFETY INFORMATION

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

INACTIVE INGREDIENT

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

STATEMENT OF IDENTITY

RECOVERY

NUMBING SPRAY

FAST-ACTING TOPICAL

ANESTHETIC WITH ALOE

NET WT 4 FL OZ (118 mL)

NDC: 76348-585-04

WHEN USING

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

PRINCIPAL DISPLAY PANEL

PRODUCT LABEL

INGREDIENTS AND APPEARANCE

RECOVERY NUMBING 
lidocaine hcl spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-980
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	5.9 g  in 118 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-980-04	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	08/01/2022

Labeler - Renu Laboratories, LLC (119451815)

Establishment
Name	Address	ID/FEI	Business Operations
Renu Laboratories, LLC		119451815	manufacture(76348-980)