GERIGARD-SKIN PROTECTANT- zinc oxide ointment 
Geri-Gentle Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Gerigard™-Skin Protectant

Drug Facts

Active Ingredient

Zinc Oxide (1.8% w/w)

Purpose

Skin Protectant

Uses

Warnings

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

Other information

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)

Principal Display Panel - 113 gm Tube Label
GERIGARD-SKIN PROTECTANT 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69771-108
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69771-108-37113 g in 1 TUBE; Type 0: Not a Combination Product01/15/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34701/15/2009
Labeler - Geri-Gentle Corporation (361663839)
Establishment
NameAddressID/FEIBusiness Operations
SKYLARK CMC PVT. LTD.650174824MANUFACTURE(69771-108)

Revised: 1/2018
Document Id: e78720ac-90b4-4ff0-aba4-8c4e8d0cc88a
Set id: a72e484d-a911-4870-b923-6650933ea902
Version: 1
Effective Time: 20180118
 
Geri-Gentle Corporation