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 FRONT PHARMACEUTICAL PLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

PURPOSE

Purpose

Topical analgesic

Skin protectant

INDICATIONS & USAGE

Uses for temprary relief from pain and itching associated

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

oozing and weeping of poison: ivy  oak  sumac

WARNINGS

Warnings

For external use only.

Do not use

• over large areas of the body
• with any other product containing diphenhydramine including those taken orally

When using this product avoid contact with eyes

Ask a doctor before use

on chicken pox  on measles

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 to 4 times daily

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

OTHER SAFETY INFORMATION

Other information store at room temperature 59° - 86° F

(15° - 30° C).

INACTIVE INGREDIENT

Inactive ingredients cetyl alcohol, glyceryl stearate se,

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

glycol, propylparaben, stearic acid, stearic alcohol, water

QUESTIONS

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

label

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS 
diphenhydramine hydrochloride, zinc acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69571-005
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 STEARATE SE (UNII: FCZ5MH785I)
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: 69571-005-02	1 in 1 BOX	03/29/2017
1	NDC: 69571-005-01	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	03/29/2017

Labeler - FRONT PHARMACEUTICAL PLC (530897792)

Establishment
Name	Address	ID/FEI	Business Operations
FRONT PHARMACEUTICAL PLC		530897792	manufacture(69571-005)