Critic Aid Skin

Product NDC: 11701-050
11-digit product format: 117010050
Labeler code: 11701
Product ID: 11701-050_e6597ee1-bc01-495b-b5f3-1503de8f37f2
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc oxide
Dosage form: PASTE
Route: TOPICAL
Labeler: Coloplast Corp
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2009-06-15
Substance: ZINC OXIDE
Active strength: 200 mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Critic Aid Skin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
416684	Internal RxNorm lookup
1486031	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
caaac1f0-437d-4185-8670-9f11b9cefe63	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
11701-050-32	2023-12-21	Critic-Aid ® Skin Paste
11701-050-32	2023-12-21	Critic-Aid ® Skin Paste
11701-050-33	2023-12-21	Critic-Aid ® Skin Paste
11701-050-33	2023-12-21	Critic-Aid ® Skin Paste
11701-050-32	2023-01-30	Critic-Aid ® Skin Paste
11701-050-32	2023-01-30	Critic-Aid ® Skin Paste
11701-050-33	2023-01-30	Critic-Aid ® Skin Paste
11701-050-33	2023-01-30	Critic-Aid ® Skin Paste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11701-050-32	Critic Aid Skin	170 g in 1 TUBE	PASTE	170		11
11701-050-33	Critic Aid Skin	71 g in 1 TUBE	PASTE	71		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11701-050-32	GM - Gram	11701-050	84b0b25f-ad8a-46b7-846d-a7e589b2a9d4	1	2012-07-24
11701-050-33	GM - Gram	11701-050	cb38b322-2b6c-4574-b50c-ac345c92219c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	CRITIC AID SKIN (ZINC OXIDE) PASTE [COLOPLAST MANUFACTURING US, LLC]	6
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	CRITIC AID SKIN (ZINC OXIDE) PASTE [COLOPLAST MANUFACTURING US, LLC]	6
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CRITIC AID SKIN (ZINC OXIDE) PASTE [COLOPLAST MANUFACTURING US, LLC]	6
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	CRITIC AID SKIN (ZINC OXIDE) PASTE [COLOPLAST MANUFACTURING US, LLC]	6
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	CRITIC AID SKIN (ZINC OXIDE) PASTE [COLOPLAST MANUFACTURING US, LLC]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11701-050	CRITIC AID SKIN (ZINC OXIDE) PASTE [COLOPLAST MANUFACTURING US, LLC]	9	Current NDC, Legacy NDC, 2 package rows	20231222_caaac1f0-437d-4185-8670-9f11b9cefe63.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 17 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DCH Rapid Relief Hemorrhoidal	LIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25%	Derma Care Research Labs	00eef84c-a72e-3343-e063-6294a90aa4d8	2024-12-19	Warnings	Exact identifier application number: M015
Formula 2 Skin Care	LIDOCAINE 5%	Derma Care Research Labs	a05d5e07-ae4b-38cc-e053-2a95a90abced	2024-12-19	Warnings	Exact identifier application number: M015
Revivol Hemorrhoid and Fissure	GLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%	Derma Care Research Labs, LLC	0140cf68-b6a0-4378-e063-6394a90afee8	2024-12-19	Warnings	Exact identifier application number: M015
Hemorroidal Cooling gel	PHENYLEPHRINE, WITCH HAZEL	Trifecta Pharmaceuticals Usa Llc	651c0143-384c-3649-e053-2991aa0a0f28	2024-12-18	Warnings	Exact identifier application number: M015
HemorrhoidalOintment	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Trifecta Pharmaceuticals USA LLC	c50cc6ad-e8a0-47c1-e053-2a95a90a4de6	2024-12-18	Warnings	Exact identifier application number: M015
HemorrhoidalOintment	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Trifecta Pharmaceuticals USA LLC	fe18fa61-83f9-8bf9-e053-6294a90a7585	2024-12-18	Warnings	Exact identifier application number: M015
HemorrhoidalOintment	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Trifecta Pharmaceuticals USA LLC	c59dcb2a-392b-670b-e053-2995a90a9682	2024-12-18	Warnings	Exact identifier application number: M015
TheraCare Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Veridian Healthcare	fab95657-d257-e671-e053-6294a90a59e0	2024-12-18	Warnings	Exact identifier application number: M015
TN Dickinsons Witch Hazel Hemorrhoidal Pads	WITCH HAZEL	Dickinson Brands Inc.	1b50f4dc-c26a-431a-ae18-c43513871b39	2024-12-18	Warnings	Exact identifier application number: M015
RECTICARE	LIDOCAINE	Ferndale Laboratories, Inc.	49cb48cf-7a26-4d7a-887f-2e98261d269d	2024-12-17	Warnings	Exact identifier application number: M015
Recticare Advanced	LIDOCAINE AND MINERAL OIL AND PHENYLEPHRINE HCL AND WHITE PETROLATUM	Ferndale Laboratories, Inc.	209212a7-7b6e-4b26-9f31-0eeb76f026bf	2024-12-17	Warnings	Exact identifier application number: M015
RECTICARE	LIDOCAINE AND GLYCERIN	Ferndale Laboratories, Inc.	2b94136a-4975-2925-e054-00144ff88e88	2024-12-17	Warnings	Exact identifier application number: M015
PRAX	PRAMOXINE HYDROCHLORIDE	Ferndale Laboratories, Inc.	674f0d8b-3d50-42b1-8401-d2967bcdf5cf	2024-12-17	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Rugby	a5b5e0a9-eee9-2a1e-e053-2a95a90a464e	2024-12-17	Warnings	Exact identifier application number: M015
Warrior Rectal Care	LIDOCAINE 4%, PHENYLEPHRINE HYDROCHLORIDE 0.25%	Derma Care Research Labs	fc10cbc3-fc1b-ae09-e053-6394a90ac8f3	2024-12-15	Warnings	Exact identifier application number: M015
Tucks Multi-Care Relief Kit (Tucks Hemorrhoidal and Tucks Medicated Cooling 40 Count)	GLYCERIN, LIDOCAINE, AND WITCH HAZEL	Blistex Inc	a7cb6d78-3048-43b3-afe7-4d862fdcfd3f	2024-12-13	Warnings	Exact identifier application number: M015
Tucks Medicated Cooling Pads	WITCH HAZEL	Blistex Inc	b3e68008-3d0d-4124-9579-b503e9fb95c9	2024-12-13	Warnings	Exact identifier application number: M015
T.N. Dickinsons Witch Hazel Medicated Cooling Pads Hemorrhoidal Relief	WITCH HAZEL	Dickinson Brands Inc.	2a4273a4-3bda-4653-a065-cd4578053f3c	2024-12-12	Warnings	Exact identifier application number: M015
Witch Hazel	WITCH HAZEL	Medical Products Laboratories, Inc.	b815792f-2f8f-7ac8-e053-2995a90ade18	2024-12-11	Warnings	Exact identifier application number: M015
Zensa	LIDOCAINE	Alera Skin Care Products Inc.	f56146b6-3c11-4608-a6ab-6142f27e9ac3	2024-11-24	Warnings	Exact identifier application number: M015

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1486031	Critic-aid Skin 20 % Paste	PSN	caaac1f0-437d-4185-8670-9f11b9cefe63	11
416684	zinc oxide 20 % Topical Paste	PSN	caaac1f0-437d-4185-8670-9f11b9cefe63	11
1486031	zinc oxide 0.2 MG/MG Paste [Critic-Aid Skin]	SBD	caaac1f0-437d-4185-8670-9f11b9cefe63	11
416684	zinc oxide 0.2 MG/MG Paste	SCD	caaac1f0-437d-4185-8670-9f11b9cefe63	11
1486031	Critic-aid Skin 0.2 MG/MG Paste	SY	caaac1f0-437d-4185-8670-9f11b9cefe63	11
1486031	Critic-aid Skin 20 % Paste	SY	caaac1f0-437d-4185-8670-9f11b9cefe63	11
416684	zinc oxide 20 % Topical Paste	SY	caaac1f0-437d-4185-8670-9f11b9cefe63	11
416684	ZNO 0.2 MG/MG Paste	SY	caaac1f0-437d-4185-8670-9f11b9cefe63	11
1486031	ZNO 0.2 MG/MG Paste [Critic-aid Skin]	SY	caaac1f0-437d-4185-8670-9f11b9cefe63	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11701-050-32	11701005032	170 g in 1 TUBE (11701-050-32)	170 g	2009-06-15	0000-00-00	No	No	Current
11701-050-33	11701005033	71 g in 1 TUBE (11701-050-33)	71 g	2009-06-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Critic-Aid ® Skin Paste	Coloplast Corp \| Coloplast Corp. \| Medline Industries, LP	2026-03-30	HUMAN OTC DRUG LABEL	11