GeriGard

GeriGard

Drug Labeling and Warnings

Drug Details

k">

GERIGARD- 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.

----------

GeriGard

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:

GeriGardNew

GERIGARD 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69771-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION18 mg  in 1 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: 69771-050-0424 in 1 CASE08/07/2018
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/07/2018
Labeler - Geri-Gentle Corporation (361663839)

Revised: 12/2019
 
Geri-Gentle Corporation


© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.