AquaSoothe by Dynarex Corporation AQUASOOTHE ointment

AquaSoothe by

Drug Labeling and Warnings

AquaSoothe by is a Otc medication manufactured, distributed, or labeled by Dynarex Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Petrolatum 41%

Purpose

Skin Protectant

Uses

Temporarily protects minor cuts scrapes burns

Temporarily protects and helps relieve chapped or cracked skin and lips

Helps protect skin from the drying effects of wind and cold weather

Warnings

For external use only

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 with a few days

Do not use

On deep or puncture wounds Animal bites Serious burns

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Other information

Store at room temperature 15º - 30ºC (59º - 86ºF)

Directions

Apply as needed

Inactive ingredients

ceresin wax, dexpanthenol, glycerin, lanoline alcohol, mineral oil

Questions?

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

Label

1465 Label

Label

1464 Label

Label

1463 Label

INGREDIENTS AND APPEARANCE

AQUASOOTHE 
aquasoothe ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-555
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	41 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
DEXPANTHENOL (UNII: 1O6C93RI7Z)
GLYCERIN (UNII: PDC6A3C0OX)
CERESIN (UNII: Q1LS2UJO3A)

Product Characteristics
Color		Score
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-555-06	12 in 1 CASE	12/16/2025
1	NDC: 67777-555-05	144 in 1 BOX
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 67777-555-04	12 in 1 CASE	12/16/2025
2	NDC: 67777-555-03	396.9 g in 1 JAR; Type 0: Not a Combination Product
3	NDC: 67777-555-02	24 in 1 CASE	12/16/2025
3	NDC: 67777-555-01	106 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	12/16/2025

Labeler - Dynarex Corporation (008124539)