AQUAGARD- hydrating ointment ointment 
Dynarex 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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1463 - AquaGard (Hydrating Ointment) NDC 67777-014-63
1464 - AquaGard (Hydrating Ointment) NDC 67777-014-64
1465 - AquaGard (Hydrating Ointment) NDC 67777-014-65

Active ingredient

Petrolatum 41%

Purpose

Skin Protectant

Uses

Warnings

For External Use Only

Avoid contact with eyes. In case of contact, flush thoroughly with water.

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Do not use

on deep puncture wounds, animal bites, or serious burns.

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

Directions

Apply as needed or as directed by a physician.

Other Information

Store at room temperature (59°-86°F).

Inactive ingredients

Ceresin Wax, Dexpanthenol, Glycerin, Lanoline Alcohol, Mineral Oil

Questions?

1-888-DYNAREX Monday-Friday, 9AM-5PM EST

Label

1463 Principal Display Panel

Label

1464 IN MASTER

Label

1465 DM MASTER1465 BX MASTER

AQUAGARD 
hydrating ointment ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM41 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
MINERAL OIL (UNII: T5L8T28FGP)  
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
CERESIN (UNII: Q1LS2UJO3A)  
DEXPANTHENOL (UNII: 1O6C93RI7Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-014-6324 in 1 CASE12/20/2019
1NDC:67777-014-03106 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:67777-014-6412 in 1 CASE12/20/2019
2NDC:67777-014-04396.9 g in 1 JAR; Type 0: Not a Combination Product
3NDC:67777-014-6512 in 1 CASE12/20/2019
3NDC:67777-014-05144 in 1 BOX
30.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/20/2019
Labeler - Dynarex Corporation (008124539)

Revised: 12/2022
Document Id: eec7c048-55f5-52b2-e053-2a95a90a95c5
Set id: 812b71ea-48ee-7e5e-e053-2a91aa0a7e57
Version: 4
Effective Time: 20221201
 
Dynarex Corporation