FIRST AID RESEARCH ZINC OXYDE PLUS- menthol and zinc oxide ointment

FIRST AID RESEARCH ZINC OXYDE PLUS by

Drug Labeling and Warnings

FIRST AID RESEARCH ZINC OXYDE PLUS by is a Otc medication manufactured, distributed, or labeled by TAI GUK PHARM. CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                                    Purpose

Menthol 0.44% .......................................................................External analgesic, first aid antiseptic

Zinc Oxide 20% .....................................................................Skin protectant/moisture barrier

PURPOSE

Uses

• A moisture barrier that prevents and helps heal skin irritations
• skin irritation from urine
• diarrhea
• perspiration
• fistula drainage
  
• minor burns
• cuts
• feeding tube
• site leakage
• wound drainage (peri-wound skin)
• scrapes
• itching
  

WARNINGS

Warning

For external use only

Not for deep or puncture wounds, avoid contact with eyes

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

In case of accidental ingestion contact a physician or Poison Control Center immediately.

DO NOT USE

Do not use

if conditions worsens or does not improve within 7 days, consult a doctor.

INDICATIONS & USAGE

Directions

• cleanse skin gently with mild skin cleanser
• pat dry or allow to air dry
• apply a thin layer of Zinc Oxyde Plus to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection
  

STORAGE AND HANDLING

Other information

• Store at 20o to 25oC (68o to 77oF)
• Lot No. and Exp. Date: see box or see crimp of tube
  

INACTIVE INGREDIENT

Inactive ingredients

Aloe Vera Gel, Butylated Hydroxytoluene, Calamine, Ergocalciferol, Liquid Paraffin, Methylparaben, Purified Lanolin, Purified Water, Retinol Palmitate, Tocopherol Acetate, Trolamine, White Petrolatum

DOSAGE & ADMINISTRATION

Distributed by:

First Aid Research Corp.

3375 Park Ave. Suite 2003

Wantagh, NY 11793

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FIRST AID RESEARCH ZINC OXYDE PLUS 
menthol and zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68169-0061
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.44 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ERGOCALCIFEROL (UNII: VS041H42XC)
MINERAL OIL (UNII: T5L8T28FGP)
METHYLPARABEN (UNII: A2I8C7HI9T)
LANOLIN (UNII: 7EV65EAW6H)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68169-0061-1	1 in 1 CARTON	10/06/2016
1		57 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 final	part347	09/28/2010

Labeler - TAI GUK PHARM. CO., LTD. (631101656)