GLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE- glycerin, lidocaine, petrolatum, and phenylephrine hydrochloride cream 
ONE2ZEE LIMITED LIABILITY COMPANY

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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Glycerin, Lidocaine, Petrolatum, and Phenylephrine Hydrochloride

DRUG FACTS:

Active Ingredient:

Glycerin 14.4%
Lidocaine 5%
Phenylephrine HCl 0.25%
White petrolatum 15%

Purpose

Uses:

Warnings:

Directions:

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.

Inactive Ingredients:

aloe vera leaf, anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, dexpanthenol, edetate disodium, glyceryl monosterate, methylparaben, mineral oil, laureth-23, steareth-2, steareth-20, propyl gallate, propylene glycol, propylparaben, sodium benzoate, tocopherol, alpha.- tocopherol acetate, xanthan gum, water

Other Information:

Store at 20-25°C (68-77°F) Do not use if tamper evident packaging has been breached or is missing.

Distributed by: Wellspring Airmont, NY 10952 U.S.A.

Package Label

Package Label

GLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE 
glycerin, lidocaine, petrolatum, and phenylephrine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55629-051
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN144 mg  in 1 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM150 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE2.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DEXPANTHENOL (UNII: 1O6C93RI7Z)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
MINERAL OIL (UNII: T5L8T28FGP)  
LAURETH-23 (UNII: N72LMW566G)  
STEARETH-2 (UNII: V56DFE46J5)  
STEARETH-20 (UNII: L0Q8IK9E08)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
XANTHAN GUM (UNII: TTV12P4NEE)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55629-051-041 in 1 CARTON02/08/2021
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34602/08/2021
Labeler - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)
Registrant - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)
Establishment
NameAddressID/FEIBusiness Operations
YASH PHARMACEUTICALS871409551manufacture(55629-051) , analysis(55629-051)

Revised: 2/2021
Document Id: 33680bc4-29a8-4475-b9c1-2e0867841ecc
Set id: e758fe66-8e87-4626-bfeb-71f6faf89a44
Version: 1
Effective Time: 20210208
 
ONE2ZEE LIMITED LIABILITY COMPANY