GERIGARD-SKIN PROTECTANT- zinc oxide ointment

Gerigard-Skin Protectant by

Drug Labeling and Warnings

Gerigard-Skin Protectant by is a Otc medication manufactured, distributed, or labeled by Geri-Gentle Corporation, SKYLARK CMC PVT. LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Zinc Oxide (1.8% w/w)

Purpose

Skin Protectant

Uses

• Helps treat and prevent diaper rash.
• Temporarily protects:
  • minor cuts
  • scrapes
  • burns
• 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 and 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 15° - 30°C (59° - 86°F)
• Avoid excessive heat
• Contains color additives including FD&C Yellow No. 5 (Tartrazine).

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL - 113 gm Tube Label

gerigentle™

VITAMIN ENRICHED
geri
gard™
SKIN PROTECTANT

SPECIALLY FORMULATED
FOR GENTLE SKIN

AloeSoft

VITAMIN A VITAMIN D VITAMIN E
ZINC OXIDE ALOE VERA

4 FL OZ (113 gm)

INGREDIENTS AND APPEARANCE

GERIGARD-SKIN PROTECTANT 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69771-108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1.8 g  in 100 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: 69771-108-37	113 g in 1 TUBE; Type 0: Not a Combination Product	01/15/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	01/15/2009

Labeler - Geri-Gentle Corporation (361663839)

Establishment
Name	Address	ID/FEI	Business Operations
SKYLARK CMC PVT. LTD.		650174824	MANUFACTURE(69771-108)