P.O.V. Baby Moisturizing Fragrance Free: Package Insert and Label Information

P.O.V. BABY MOISTURIZING FRAGRANCE FREE- dimethicone 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 ingredient

Dimethicone 1.2%

Purpose

Skin Protectant

Uses

temporarily protects and helps relieve chapped or cracked skin, and helps protect from the drying effects of wind and cold.

Warnings

For external use only.

When using this product

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

Stop use and ask a doctor if

condition worsens, or if irritation or redness develops and lasts more than 7 days, or clears up and recurs within a few days.

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), Glycerin, Petrolatum, Isopropyl Palmitate, Distearyldimonium Chloride, Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Sodium Chloride, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol.

Questions or comments?

1-866-695-3030

Label Copy

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P.O.V. BABY MOISTURIZING FRAGRANCE FREE
dimethicone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63148-319
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 12 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
PETROLATUM
ISOPROPYL PALMITATE
DISTEARYLDIMONIUM CHLORIDE
CETYL ALCOHOL
OATMEAL
SODIUM CHLORIDE
SODIUM HYDROXIDE
ETHYLHEXYLGLYCERIN
PHENOXYETHANOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63148-319-18 532 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 11/24/2017
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 (63148-319)

Revised: 11/2017 Apollo Health and Beauty Care Inc.

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