FDA.reportPublic FDA data

P.O.V Itch Relief Body

Manufacturer
Apollo Health and Beauty Care Inc.
Effective date
2018-03-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:03

Label at a glance#

ProductP.O.V Itch Relief Body
Active ingredientDIMETHICONE, MENTHOL
Label structure8 sections

Indications and uses

temporarily protects and helps relieve chapped or cracked skin. temporarily relieves itching associated with: minor skin irritations, minor burns, rashes due to poison ivy, oak and sumac insect bites sunburn

Dosage and administration

apply as needed

Storage and handling

store at room temperature.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 5.0%, Menthol 0.5%

Purpose

OTC - PURPOSE SECTION

Skin Protectant, Anti-itch

Uses

INDICATIONS & USAGE SECTION

  • temporarily protects and helps relieve chapped or cracked skin.
  • temporarily relieves itching associated with: minor skin irritations, minor burns, rashes due to poison ivy, oak and sumac
  • insect bites
  • sunburn

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wournds
  • animal bites
  • serious burns
Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness, irritation, swelling or pain persists or increases
Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

apply as needed

Other information

STORAGE AND HANDLING SECTION

store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Cetearyl Alcohol, Cetyl Alcohol, Polysorbate 60, Distearyldimonium Chloride, Glycerin, Stearamidopropyl PG-Dimonium Chloride Phosphate, Petrolatum, Aloe Barbadensis Leaf Juice, Stearyl Alcohol, Steareth-2, Steareth-21, Tocopheryl Acetate, Tetrasodium EDTA, Benzyl Alcohol, Iodopropynyl Butylcarbamate, Fragrance (Parfum).

Questions or comments?

OTC - QUESTIONS SECTION

1-866-695-3030

Label Copy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of the labelimage of the label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053386dimethicone 5 % / menthol 0.5 % Topical LotionPSN1
1053386dimethicone 50 MG/ML / menthol 5 MG/ML Topical LotionSCD1
1053386dimethicone 5 % / menthol 0.5 % Topical LotionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63148-562-142024-01-30C16284748780-11030e365-67d6-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63148-562-14P.O.V Itch Relief Body414 mL in 1 BOTTLE, PLASTICLOTION4141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63148-562P.O.V ITCH RELIEF BODY (DIMETHICONE, MENTHOL) LOTION [APOLLO HEALTH AND BEAUTY CARE INC.]1Legacy NDC, 1 package rows20180330_0b394675-00de-4d9c-bb31-dc79218de647.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63148-56263148-562-14

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
MENTHOLL7T10EIP3AACTIB
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
POLYSORBATE 60CAL22UVI4MIACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
GLYCERINPDC6A3C0OXIACT
STEARAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEW6000VEI5YIACT
PETROLATUM4T6H12BN9UIACT
ALOE VERA LEAFZY81Z83H0XIACT
STEARYL ALCOHOL2KR89I4H1YIACT
STEARETH-2V56DFE46J5IACT
STEARETH-2153J3F32P58IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
EDETATE SODIUMMP1J8420LUIACT
BENZYL ALCOHOLLKG8494WBHIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
039f68a1-2ab4-4458-ac3e-0dcd98993c090b394675-00de-4d9c-bb31-dc79218de6472018-03-29WarningsExact identifier
spl id: 039f68a1-2ab4-4458-ac3e-0dcd98993c09
spl set id: 0b394675-00de-4d9c-bb31-dc79218de647

Reported adverse events (FAERS/openFDA)#

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