RECOVERY NUMB- lidocaine hydrochloride cream
Sambria Pharmaceucals, 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.

----------

Recovery Numb Cream

Drug Facts

Active Ingredient

Lidocaine HCl (5.00%)

Purpose

Local Anesthetic

Uses:

For temporary relief of local discomfort, itching, pain, soreness or burning in the perianal area associated with anorectal disorders.

Warnings:

For external use only

When using this product

Do not exceed the recommended daily dosage unless directed by a doctor
Do not put into the rectum by using fingers any mechanical device or applicator

Stop use and ask a doctor if

Allergic reacion 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.

Questions or Comments?

support@recoveryaftercare.com

Directions:

- Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.

- When first opening the tube, twist the cap and peel off the foil seal

- Apply externally to the affected area up to 6 times daily

- Children under 12 years of age: consult a doctor

Other Information:

- Always keep the tube tightly closed.

- Store at a temperatures not exceeding 15 C - 30 C

- Protect from freezing

Inactive Ingredients:

Aqua (Deionized Water), Arnica Montana Extract, C13-14 Isoparaffin, Chrondroitin Sulfate, Emul Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonyl Methane (MSM), Phenoxyethanol, Polyacralamide, Propylene Gycol, Stearic Acid, Triethanolamine

Product Label

BoxLabel

RECOVERY NUMB
lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54723-638
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.05 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA (UNII: O80TY208ZW)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
EMU OIL (UNII: 344821WD61)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
LAURETH-7 (UNII: Z95S6G8201)
TEA TREE OIL (UNII: VIF565UC2G)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54723-638-63	1 in 1 BOX	03/22/2013	06/29/2017
1		63 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/22/2013	06/29/2017

Labeler - Sambria Pharmaceucals, Inc. (078676259)

Revised: 6/2016

Document Id: 3362de9b-0024-47fe-a221-bcdf6ba274c0

Set id: 29fdc22c-4fb6-4d70-8697-86d449c7d034

Version: 5

Effective Time: 20160608

Sambria Pharmaceucals, Inc.