GERIGARD- zinc oxide ointment

GeriGard by

Drug Labeling and Warnings

GeriGard by is a Otc medication manufactured, distributed, or labeled by Geri-Gentle Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Zinc Oxide (1.8% w/w)

Purpose

Skin Prorectant

Uses:

• Helps treat and prevent diaper rash.
• Helps seal out wetness.
• Dries the oozing and weeping of:
• poison ivy 
• poison oak 
• poison sumac

Warnings:

For external use only

When using this product

• Do not get into eyes

Stop use nd ask a doctor if:

• Condition worsens
• Symptoms last more than 7 days or clear up and occur again in a few days, consult a physician

Keep out of reach of children

• If swallowed, get medical help or contact a Poison Control Center right away

Directions:

• Apply liberally as needed
• For diaper rash: 
• change wet and soiled diapers promptly 
• allow to dry
• Apply ointment liberally with each diaper change

Other information:

• Store at room temperature 15º - 30ºC (59º - 86ºF)
• Avoid excessive heat
• Contains color additives including FD&C Yellow No. 5 (Tartrazine).

Inactive ingredients:

Aloe Vera Leaf, Alpha-Tocopherol, Ceteth-10, Cetostearyl Alcohol, Cetyl Alcohol, Cholecalciferol, Glycerin, Lanolin, Lavender, Methylparaben, Mineral Oil, Paraffin, Petrolatum, Phenoxyethanol, Polyethylene Glycol 6000, Polysorbate 60, Propylparaben Sodium, Steareth-20, Trolamine, Vitamin A, Water.

Package Labeling:

INGREDIENTS AND APPEARANCE

GERIGARD 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69771-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	18 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
CETETH-10 (UNII: LF9X1PN3XJ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
GLYCERIN (UNII: PDC6A3C0OX)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
STEARETH-20 (UNII: L0Q8IK9E08)
TROLAMINE (UNII: 9O3K93S3TK)
VITAMIN A (UNII: 81G40H8B0T)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69771-050-04	24 in 1 CASE	08/07/2018
1		113 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	08/07/2018

Labeler - Geri-Gentle Corporation (080367686)