MAKESENSE FIRST AID- lidocaine hydrochloride phenol cream 
Cherry Hill Sales Co

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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Drug Facts

Active ingredients

Lidocaine HCl 0.5%

Phenol 0.5%

Purpose

Topical Analgesic

Antiseptic

Uses

■ for the temporary relief of pain associated with minor cuts, scrapes or minor burns ■ first aid to help prevent the risk of skin infection in minor cuts, scrapes or minor burns

Warnings

For external use only

Do not use

■ in eyes ■ over large areas of the body ■ with a bandage

Stop use and consult a doctor if

■ in cases of deep or puncture wounds, animal bites or serious burns ■ if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product ■ if redness, irritation, swelling, pain or other symptoms develop or increase

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ Cleanse affected area ■ Apply a small amount of this product (an amount equal to the surface of a finger) on the area 1 to 3 times daily

Other Information

■ store at room temperature 59 to 86F (15 to 30C) ■ see carton or tube crimp for lot number and expiration date

Inactive ingredients

Cetearyl Alcohol, Glyceryl Stearate, Methylparaben, Mineral Oil, Petrolatum, Polysorbate 60, Propylene Glycol, Propylparaben, Purified Water, Sorbitan Stearate, Stearic Acid

Package Label

image description

MAKESENSE  FIRST AID
lidocaine hydrochloride phenol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69020-210
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69020-210-2828 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/31/2014
Labeler - Cherry Hill Sales Co (145959768)

Revised: 8/2014
Document Id: b0528b58-df31-46c8-8b0b-b3bf03d0480e
Set id: 9b4666e0-d7c8-4b50-aa0c-c6a7b8e52617
Version: 1
Effective Time: 20140807
 
Cherry Hill Sales Co