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Critic Aid Skin Prescribing Information

Package insert / product label
Generic name: petrolatum and zinc oxide
Dosage form: paste
Drug class: Miscellaneous topical agents

Medically reviewed by Drugs.com. Last updated on Jan 23, 2023.

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.

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

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)

Critic Aid Skin
zinc oxide paste
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11701-050
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 200 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM
DIMETHICONE
CROSCARMELLOSE SODIUM
Packaging
# Item Code Package Description
1 NDC:11701-050-33 71 g in 1 TUBE
2 NDC:11701-050-32 170 g in 1 TUBE
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 Operations
Coloplast Manufacturing US, LLC 110326675 MANUFACTURE(11701-050)
Coloplast Manufacturing US, LLC