CRITIC AID SKIN- zinc oxide paste

Critic Aid Skin by

Drug Labeling and Warnings

Critic Aid Skin by is a Otc medication manufactured, distributed, or labeled by Coloplast Manufacturing US, LLC, Coloplast Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Zinc Oxide: 20%

Purpose

Skin Protectant

Uses

• Helps protect minor skin irritation due to diaper rash
• Protects chafed skin due to diaper rash
• Helps seal out wetness

Warnings

For external use only.

When using this product:

• avoid contact with eyes

Consult a doctor:

• if condition worsens or does not improve within 7 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 right away.

Directions

• Clean the affected area and dry thoroughly
• Apply a thin layer of product over affected area twice daily (morning and night), or as directed by a doctor.
• Change wet and soiled absorbent brief/diapers promptly.

Inactive ingredients

Cellulose Gum (CMC), Dimethicone, Petrolatum

Questions or comments?

Call toll free 1-800-533-0464

SPL UNCLASSIFIED SECTION

Manufactured by: Coloplast A/S
Holtedam 1, DK-3050 Humlebaek, Denmark

Distributed by: Coloplast Corp
1601 W River Rd. N, Minneapolis, MN 55411 USA

PRINCIPAL DISPLAY PANEL - 170 g Tube Label

NDC: 11701-050-32

Critic-Aid® Skin Paste

Skin Protectant

Thick Moisture
Barrier Paste

For Minor to
Severe Skin Irritation
Due to Incontinence

Product #1947

Coloplast

NET WT. 6 OZ. (170 g)

INGREDIENTS AND APPEARANCE

CRITIC AID SKIN 
zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11701-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11701-050-33	71 g in 1 TUBE; Type 0: Not a Combination Product	06/15/2009
2	NDC: 11701-050-32	170 g in 1 TUBE; Type 0: Not a Combination Product	06/15/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	06/15/2009

Labeler - Coloplast Manufacturing US, LLC (110326675)

Registrant - Coloplast Corp (847436391)

Establishment
Name	Address	ID/FEI	Business Operations
Coloplast Manufacturing US, LLC		110326675	MANUFACTURE(11701-050)