CRITIC-AID CLEAR- petrolatum ointment

Critic-Aid Clear by

Drug Labeling and Warnings

Critic-Aid Clear by is a Otc medication manufactured, distributed, or labeled by Coloplast Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Petrolatum, 86.5%

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve chapped or cracked skin. Helps seal out wetness.

WARNINGS

For external use only.

When using this product

• Do not get into eyes.

• Do not use on:
  • deep or puncture wounds
  • animal bites
  • serious burns.

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.

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Clean the affected area and dry thoroughly.
• Knead before use.
• Apply a thin layer liberally enough to cover yet visualize the skin.
• Apply to the affected area twice daily (morning and night), or as directed by a doctor.
• Supervise children in the use of this product.

Inactive ingredients

cellulose gum (CMC), dimethicone, tocopheryl acetate, zinc oxide

SPL UNCLASSIFIED SECTION

Manufactured by: Coloplast Corp., 1940 Commerce Drive,
North Mankato, MN 56003

Distributed by: Coloplast Corp. 1601 West River Road,
Minneapolis, MN 55411, U.S.A.

PRINCIPAL DISPLAY PANEL - 170 g Tube Label

NDC: 11701-083-32

Critic-Aid® Clear

Skin Protectant

Clear
Moisture Barrier
Ointment

For Minor to Severe
Skin Irritation
Due to Incontinence

Coloplast

NET WT. 6 oz. (170 g)

INGREDIENTS AND APPEARANCE

CRITIC-AID CLEAR 
petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11701-083
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U)	Petrolatum	865 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Zinc Oxide (UNII: SOI2LOH54Z)
.Alpha.-Tocopherol Acetate, DL- (UNII: WR1WPI7EW8)
Carboxymethylcellulose Sodium, Unspecified Form (UNII: K679OBS311)
Dimethicone 1000 (UNII: MCU2324216)

Product Characteristics
Color	WHITE (Rubs to clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11701-083-22	4 g in 1 PACKET; Type 0: Not a Combination Product	01/22/2019
2	NDC: 11701-083-33	71 g in 1 TUBE; Type 0: Not a Combination Product	01/22/2019
3	NDC: 11701-083-32	170 g in 1 TUBE; Type 0: Not a Combination Product	01/22/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	01/22/2019

Labeler - Coloplast Corp. (110326675)

Establishment
Name	Address	ID/FEI	Business Operations
Coloplast Corp.		110326675	MANUFACTURE(11701-083)