Hemorrhoid, Fissure, Proctalgia Ointments

Product NDC

84533-003

Requested package NDC

84533-003-01

11-digit product format

845330003

Labeler code

84533

Product ID

84533-003_48652f88-8d2e-2b65-e063-6394a90afb34

Type

HUMAN OTC DRUG

Nonproprietary name

Carbon, Mirabilite, Peppermint oil, Borneol, Glycerin

Dosage form

SALVE

Route

TOPICAL

Labeler

WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.

Application

M015

Marketing category

OTC MONOGRAPH DRUG

Marketing start

2024-08-06

Substance

ACTIVATED CHARCOAL; BORNEOL; GLYCERIN; PEPPERMINT OIL; SODIUM SULFATE

Active strength

1; 3; 8; .2; 2 g/100g; g/100g; g/100g; g/100g; g/100g

Pharmacologic classes

Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]

NDC exclude flag

No

Listing certified through

2027-12-31

Current FDA listing

Yes