Recovery Inc. NUMB CREAM

Recovery Inc. NUMB CREAM

Drug Labeling and Warnings

Drug Details

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ANECREAM- lidocaine 4% cream 
PURKLENZ FORMULATIONS 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 Inc. NUMB CREAM

DRUG FACTS

Active Ingredients: Lidocaine 4% w/w

Purpose: Topical Anesthetic

Uses: Temporarily relieves pain and itching
due to minor cuts, minor scrapes, sunburn,
minor skin irritations, minor burns, insect bites.

WARNINGS: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.

Stop use and ask 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 externally to the affected area up
to 3-4 times daily.
Children under 2 years of age: Consult a
doctor.

Other Information: Store at room
temperature 20°C and 25°C (68°F to
77°F).

Inactive ingredients: Benzyl Alcohol,
Carbomer 940, Cholesterol, Hydrogenated
Lecithin, Polysorbate 80, Propylene Glycol,
Tocopherol Acetate, Trolamine, Water

Package Label

NUMB

CREAM

NET WT 1 oz (30g)

NDC: 49426-099-30

Lidocaine 4% Cream

RECOVERYAFTERCARE.COM

Made in USA

Distributed by Recovery, Inc.

Hanover, MD  21076

©​ Recovery, Inc. 2019

Questions or comments?

[email protected]

RECOVERY

7  49110 22144  7

image description

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ANECREAM 
lidocaine 4% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49436-099
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49436-099-3030 g in 1 TUBE; Type 0: Not a Combination Product12/10/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/10/2019
Labeler - PURKLENZ FORMULATIONS INC. (078444179)

Revised: 1/2020
 
PURKLENZ FORMULATIONS INC.


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