Gerigentle-Vitamins A and D

Gerigentle-Vitamins A and D

Drug Labeling and Warnings

Drug Details

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GERIGENTLE-VITAMINS A AND D- petrolatum 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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Gerigentle-Vitamins A and D

Drug Facts

Active ingredient

White Petrolatum USP (93%w/w)

Purpose

Skin Protectant

Uses

  • Helps treat and prevent diaper rash
  • Helps seal out wetness
  • Temporarily protects minor
    • cuts
    • scrapes
    • burns
  • Temporarily helps protect and relieve chapped and cracked skin or lips
  • Helps prevent and protect from the drying effects of wind and cold weather
  • Helps prevent and protect chafed skin or minor skin irritations associated with diaper rash
  • With each diaper change, especially at bedtime when exposure to wetness may be prolonged

Warnings

For external use only

When using this product

  • Do not get into eyes

Stop Use and consult a doctor if

  • condition worsens
  • symptoms last more than 7 days
  • symptoms clear up and reoccur in a few days

Do not use on

  • deep puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children! If swallowed, get medical help or contact a Poison Control Center immediately

Directions for use with Diaper Rash

  • change wet and soiled diaper promptly
  • cleanse the diaper area and allow to dry
  • apply as needed

Other information

  • store at 15°-30°C (59°-86°F)
  • avoid excessive heat and humidity

Inactive Ingredients

  • Lanolin, Lavender Oil, Light Liquid Paraffin, Vitamin A and Vitamin D

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

GeriGentle

Vitamins A&D
Ointment

DIAPER RASH OINTMENT
SKIN PROTECTANT 4 oz

Net Wt 4oz (113g)
12 Tubes

Reorder No.
16035

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
GERIGENTLE-VITAMINS A AND D 
petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69771-105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum0.93 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Lanolin (UNII: 7EV65EAW6H)  
Lavender Oil (UNII: ZBP1YXW0H8)  
Light Mineral Oil (UNII: N6K5787QVP)  
Vitamin A (UNII: 81G40H8B0T)  
VITAMIN D (UNII: 9VU1KI44GP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69771-105-3312 in 1 CARTON01/15/2015
1113 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 69771-105-325 g in 1 PACKET; Type 0: Not a Combination Product01/15/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34701/15/2015
Labeler - Geri-Gentle Corporation (361663839)
Establishment
NameAddressID/FEIBusiness Operations
SKYLARK CMC PVT. LTD.650174824MANUFACTURE(69771-105)

Revised: 1/2018
 
Geri-Gentle Corporation


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