LIFE IS HEALED  DAILY MOISTURIZING- dimethicone lotion 
Apollo Health and Beauty Care

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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63148-028, life is healed

Active Ingredient.

Dimethicone (1.2%)

Purpose

Skin Protectant

Uses

helps prevent and temporarily protects chafed, chapped or cracked skin.

Warnings

For external use only.

When using this product

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

Stop using this product and ask a doctor if

condition worsens or symptoms persist for more than seven days or occur again 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.

Inactive Ingredients

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

PDP05

PDP05

LIFE IS HEALED   DAILY MOISTURIZING
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-028
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE12 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PETROLATUM (UNII: 4T6H12BN9U)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
OATMEAL (UNII: 8PI54V663Y)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63148-028-05532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/20/2021
Labeler - Apollo Health and Beauty Care (201901209)
Registrant - Apollo Health and Beauty Care (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Apollo Health and Beauty Care201901209manufacture(63148-028)

Revised: 9/2022
Document Id: e8744d84-8d37-6b55-e053-2a95a90af4d0
Set id: e31f3fcf-cab7-4e25-8ab2-0d0a4d526faf
Version: 2
Effective Time: 20220912
 
Apollo Health and Beauty Care