FAMILY WELLNESS- benzocaine, resorcinol cream
Zhejiang Jingwei Pharmaceutic Al Co., Ltd.

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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Active ingredients

Benzocaine 20%

Resorcinol 3%

Purpose

External Analgesic

Uses temporarily relieves itching

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. If

swallowed, get medical help or contact

a Poison Control Center right away.

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

Other information

Atore at 20° - 25° C (68° - 77° F).

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

image description

FAMILY WELLNESS
benzocaine, resorcinol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55621-014
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	2 g in 100 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK)	RESORCINOL	0.03 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55621-014-01	1 in 1 CARTON	08/03/2017	04/01/2021
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/03/2017	04/01/2021

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

Name	Address	ID/FEI	Business Operations
Establishment
Zhejiang Jingwei Pharmaceutic Al Co., Ltd.		530876549	manufacture(55621-014)

Revised: 12/2019

Document Id: 9a0f6322-be80-d8f7-e053-2995a90a50ad

Set id: fd158462-5982-4aea-b9dc-6ddab6b319d3

Version: 2

Effective Time: 20191219

Zhejiang Jingwei Pharmaceutic Al Co., Ltd.