FIRST AID- lidocaine hcl and phenol cream 
Universal Distribution Center LLC

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.

----------

First Aid Cream

Active Ingredients

Lidocaine HCl 0.5%

Phenol 0.5%

Purpose

Topical Anesthetic

Antiseptic

Uses

Warnings

For external use only

Do not use in eyes, do not apply over large areas of the body. In case of deep puncture wounds or serious burns, consult a doctor.

Stop use and ask a doctor if redness, irritation, swelling, or pain persists or increases or if infection develops.

Keep out of reach of children.

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

Directions

Other Information

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL

First Aid Cream
NET WT 1 OZ (28 g)

image of package label

FIRST AID 
lidocaine hcl and phenol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-027
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.005 g  in 1 g
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL0.005 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52000-027-371 in 1 CARTON08/04/2016
1NDC:52000-027-3928 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/04/2016
Labeler - Universal Distribution Center LLC (019180459)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52000-027)

Revised: 2/2022
Document Id: d886ff5e-6be4-039a-e053-2995a90a5835
Set id: 77f418a9-16b4-49d6-9e3c-2454e3fc5ac1
Version: 3
Effective Time: 20220221
 
Universal Distribution Center LLC