P.O.V ITCH RELIEF BODY- dimethicone, menthol lotion

P.O.V Itch Relief Body by

Drug Labeling and Warnings

P.O.V Itch Relief Body by is a Otc medication manufactured, distributed, or labeled by Apollo Health and Beauty Care Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Dimethicone 5.0%, Menthol 0.5%

Purpose

Skin Protectant, Anti-itch

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

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

INGREDIENTS AND APPEARANCE

P.O.V ITCH RELIEF BODY 
dimethicone, menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63148-562
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	50 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63148-562-14	414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/28/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/28/2018

Labeler - Apollo Health and Beauty Care Inc. (201901209)

Registrant - Apollo Health and Beauty Care Inc. (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
Apollo Health and Beauty Care Inc.		201901209	manufacture(63148-562)