FAMILY WELLNESS- benzocaine, resorcinol cream

Family Wellness by

Drug Labeling and Warnings

Family Wellness by is a Otc medication manufactured, distributed, or labeled by Zhejiang Jingwei Pharmaceutic Al Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Benzocaine  20%

Resorcinol  3%

PURPOSE

Purpose

External Analgesic

External Analgesic

INDICATIONS & USAGE

Uses temporarily relieves itching

WARNINGS

Warnings For external use only.

When using this product avoid contact

with the eyes.

Stop use and ask a doctor if condition

worsens, or if symptoms persists for

more than 7 days or clear up and occur

again within a few days.

Do not apply over large areas of the body.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If

swallowed, get medical help or contact

a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

Adults and children 12 years and older:

apply a fingertip amount (approximately

1 inch strip) to the affected area not

more than 3 to 4 times daily.

Children udner 12 years: ask a doctor

STORAGE AND HANDLING

Other information

Atore at 20° -  25°  C (68° -  77° F).

INACTIVE INGREDIENT

Inactive ingredients

Aloe barbadensis leaf juice,

Cetyl alcohol, Cholecalciferol,

EDTA, Fragrance, Glyceryl

stearate, Isopropyl myristate,

Isopropyl palmitate, Lanolin,

Methylparaben, Mineral Oil,

Petrolatum, Propylene glycol,

Retinol, Sodium lauryl sulfate,

Sodium Sulfate, Tocopherol,

Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS 
benzocaine, resorcinol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55621-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g  in 100 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK)	RESORCINOL	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
EDETIC ACID (UNII: 9G34HU7RV0)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
RETINOL (UNII: G2SH0XKK91)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM SULFATE (UNII: 0YPR65R21J)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55621-016-01	1 in 1 CARTON	08/20/2017
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/20/2017

Labeler - Zhejiang Jingwei Pharmaceutic Al Co., Ltd. (530876549)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Jingwei Pharmaceutic Al Co., Ltd.		530876549	manufacture(55621-016)