FDA.reportPublic FDA data

Putrizen Tea Tree Oil Antifungal Cream

Product NDC
84983-030
11-digit product format
849830030
Labeler code
84983
Product ID
84983-030_500846e1-190d-91fb-e063-6394a90a157f
Type
HUMAN OTC DRUG
Nonproprietary name
GLYCERIN
Dosage form
CREAM
Route
TOPICAL
Labeler
Shantou South Moon Biotechnology Co., Ltd.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-22
Substance
ALLANTOIN; ALOE VERA LEAF; CHAMAEMELUM NOBILE FLOWER; EUCALYPTUS GLOBULUS LEAF; LAVENDER OIL; LICORICE; MENTHA PIPERITA LEAF; PANTHENOL; TEA TREE OIL; UNDECYLENIC ACID
Active strength
.02; 1.5; .8; .35; .8; .4; .3; .8; 2; 1.5 mg/100mg; mg/100mg; mg/100mg; mg/100mg; mg/100mg; mg/100mg; mg/100mg; mg/100mg; mg/100mg; mg/100mg
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Putrizen Tea Tree Oil Antifungal Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLANTOIN.02 mg/100mg
ALOE VERA LEAF1.5 mg/100mg
CHAMAEMELUM NOBILE FLOWER.8 mg/100mg
EUCALYPTUS GLOBULUS LEAF.35 mg/100mg
LAVENDER OIL.8 mg/100mg
LICORICE.4 mg/100mg
MENTHA PIPERITA LEAF.3 mg/100mg
PANTHENOL.8 mg/100mg
TEA TREE OIL2 mg/100mg
UNDECYLENIC ACID1.5 mg/100mg

Harmonized Identifiers#

Field, Values table
FieldValues
Unii344S277G0Z, ZY81Z83H0X, O2T154T6OG, S546YLW6E6, ZBP1YXW0H8, 61ZBX54883, A389O33LX6, WV9CM0O67Z, VIF565UC2G, K3D86KJ24N

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84983-030-01Putrizen Tea Tree Oil Antifungal Cream100 mg in 1 BOTTLE, PLASTICCREAM1002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84983-030-0184983003001100 mg in 1 BOTTLE, PLASTIC (84983-030-01) 100 mg2026-04-22NoNoHistorical