FAMILY WELLNESS- glycerin, phenylephrine hcl, pramoxine hcl, petrolatum cream 
FRONT PHARMACEUTICAL PLC

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Active ingredients (in each gram)

Glycerin 14.4%

Phenylephrine HCL 0.25%

Pramoxine HCL 1%

White petrolatum 15%

Purpose

Protectant

Vasoconstrictor

Local anesthetic

Protectant

Uses

Warnings

. For external use only

When using this product

Ask a doctor before use if you have

•heart disease  •high blood pressure  •thyroid disease  •diabetes

•trouble urinating due to an enlarged prostate gland

you are presently taking a prescription Ask a doctor or pharmacist before use if

drug for high blood pressure.

Stop use and ask a doctor if

•bleeding occurs  •condition worsens or does not improve within 7 days

-if the symptoms being treated do not subside or ir redness, irritation, swelling,

pain or other symptoms develop or increase. Some people can develop allergic

reactions to ingredients in this product.

, ask a health professional before use. If pregnant or breast-feeding

. If swallowed, get medical help or contact a Keep out of reach of children

Poison Control Center right away.

Adults: Directions

-when practical, cleanse the affected area with mild soap and warm water and

rinse thoroughly. Gentlydry by patting or blotting with toilet tissue or a soft

cloth before application of this product.

-apply externally to the affected area up to 4 times daily especially at night r

in the morningor after each bowel movement.

hildren under 12 years of age: consult a doctor.

  store at room temperature 68° - 77° F (20° - 25° C) Other information

aloe barbadensis leaf extract, Inactive ingredients

carboxymethylcellulose sodium, cetyl alcohol, glyceryl monostearate,

methylparaben, paraffin, propylene glycol, propylparaben, stearic acid, tween 80,

water, xanthan gum

image description

FAMILY WELLNESS 
glycerin, phenylephrine hcl, pramoxine hcl, petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69571-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN14.4 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE0.25 g  in 100 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PARAFFIN (UNII: I9O0E3H2ZE)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69571-004-021 in 1 BOX03/14/2017
1NDC:69571-004-0126 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01503/14/2017
Labeler - FRONT PHARMACEUTICAL PLC (530897792)
Establishment
NameAddressID/FEIBusiness Operations
FRONT PHARMACEUTICAL PLC530897792manufacture(69571-004)

Revised: 10/2023
Document Id: 08a17869-d45f-18ce-e063-6394a90adbbb
Set id: eb1785f4-5876-443b-b175-9b59d65d1a48
Version: 6
Effective Time: 20231026
 
FRONT PHARMACEUTICAL PLC