P.O.V ITCH RELIEF BODY- dimethicone, menthol lotion 
Apollo Health and Beauty Care Inc.

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.

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Drug Facts

Active ingredients

Dimethicone 5.0%, Menthol 0.5%

Purpose

Skin Protectant, Anti-itch

Uses

Warnings

For external use only

When using this product

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

Do not use on

  • deep or puncture wournds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • 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.

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

Directions

apply as needed

Other information

store at room temperature.

Inactive ingredients

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?

1-866-695-3030

Label Copy

image of the label

P.O.V ITCH RELIEF BODY 
dimethicone, menthol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-562
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE50 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEARAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: W6000VEI5Y)  
PETROLATUM (UNII: 4T6H12BN9U)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
STEARETH-2 (UNII: V56DFE46J5)  
STEARETH-21 (UNII: 53J3F32P58)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
EDETATE SODIUM (UNII: MP1J8420LU)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63148-562-14414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/28/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/28/2018
Labeler - Apollo Health and Beauty Care Inc. (201901209)
Registrant - Apollo Health and Beauty Care Inc. (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Apollo Health and Beauty Care Inc.201901209manufacture(63148-562)

Revised: 3/2018
Document Id: 039f68a1-2ab4-4458-ac3e-0dcd98993c09
Set id: 0b394675-00de-4d9c-bb31-dc79218de647
Version: 1
Effective Time: 20180329
 
Apollo Health and Beauty Care Inc.