FAMILY WELLNESS- diphenhydramine hydrochloride, zinc acetate cream

Family Wellness by

Drug Labeling and Warnings

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

Drug Details [pdf]

INACTIVE INGREDIENT

Inactive Ingredients - cetyl alcohol, glycerol stearate,

laureth-23, methylparaben, mineral oil, petrolatum, propylene

glycol, propylparaben, stearic acid, stearyl alcohol, water

ACTIVE INGREDIENT

Active Ingredients

Diphenhydramine hydrochloride 2 %

Zinc acetate 0.1 %

PURPOSE

Purpose

---Topical analgesic

---Skin protectant

INDICATIONS & USAGE

Uses  for temporary relief from pain and itching associated

with insect bites, sunburn and minor skin irritations. Dries the

oozing and weeping of poison: -ivy -oak - sumac

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

-over large areas of the body

-with any other product containing diphenhydramine,

including those taken orally

WHEN USING

When using this product - avoid contact with eyes

ASK DOCTOR

Ask a doctor before use

-on chicken pox

-on measles

STOP USE

Stop use and ask a doctor if:

-symptoms last for more than 7 days

-the condition gets worse

-symptoms clear up and then occur again within a few days

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

-for adults and children over 2 years of age: apply to affected area

not more than 3 or 4 times per day

-children under 2 years of age: ask a doctor before use

STORAGE AND HANDLING

Other information - store at room temperature 59 - 86 F (15 - 30 C)

QUESTIONS

Questions? 1-800-639-3803 Weekdays 9 AM to 4 PM EST

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS 
diphenhydramine hydrochloride, zinc acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55621-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	2 g  in 100 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LAURETH-23 (UNII: N72LMW566G)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55621-007-01	1 in 1 BOX	11/01/2013
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	11/01/2013

Labeler - Zhejiang Jingwei Pharmaceutical Co., Ltd. (530876549)