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.

----------

Drug Facts

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

Image of the label

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	12 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PETROLATUM (UNII: 4T6H12BN9U)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
CETYL ALCOHOL (UNII: 936JST6JCN)
OATMEAL (UNII: 8PI54V663Y)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63148-319-18	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/24/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	11/24/2017

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

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

Name	Address	ID/FEI	Business Operations
Establishment
Apollo Health and Beauty Care Inc.		201901209	manufacture(63148-319)