FAMILY WELLNESS- glycerin, phenylephrine hydrochloride, pramoxine hydrochloride, petrolatum cream 
Zhejiang Jingwei Pharmaceutical Co., Ltd.

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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

-do not put this product into the rectum by using fingers or any mechanical device or applicator

-do not exceed recommended daily dosage unless directed by a doctor

Ask a doctor before use if you have

-heart disease  -high blood pressure  -thyroid disease  -diabetes

-trouble urinating due to an enlarged prostate gland

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

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 if 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. Gently dry 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 or -

in the morningor after each bowel movement.

Children 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 hydrochloride, pramoxine hydrochloride, petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55621-012
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:55621-012-011 in 1 BOX07/14/2016
126 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01507/14/2016
Labeler - Zhejiang Jingwei Pharmaceutical Co., Ltd. (530876549)

Revised: 10/2023
Document Id: 08835b51-a1a6-985b-e063-6294a90a14c9
Set id: fde9cd90-d63c-4058-b46e-511fecea36ec
Version: 3
Effective Time: 20231024
 
Zhejiang Jingwei Pharmaceutical Co., Ltd.