OTC Medication Information: P.O.V Itch Relief Body

P.O.V ITCH RELIEF BODY- dimethicone and 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.

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

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 50 mg in 1 mL
MENTHOL (MENTHOL) MENTHOL 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CETOSTEARYL ALCOHOL
CETYL ALCOHOL
POLYSORBATE 60
DISTEARYLDIMONIUM CHLORIDE
GLYCERIN
STEARAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE
PETROLATUM
ALOE VERA LEAF
STEARYL ALCOHOL
STEARETH-2
STEARETH-21
.ALPHA.-TOCOPHEROL ACETATE, DL-
EDETATE SODIUM
BENZYL ALCOHOL
IODOPROPYNYL BUTYLCARBAMATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63148-562-14 414 mL in 1 BOTTLE, PLASTIC None
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 Operations
Apollo Health and Beauty Care Inc. 201901209 manufacture (63148-562)

Revised: 03/2018 Apollo Health and Beauty Care Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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