Label: XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN- dimethicone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58503-038-01, 58503-038-02 - Packager: China Ningbo Shangge Cosmetic Technology Corp.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated September 12, 2019
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive Ingredients
water, paraffinum liquidum, isopropyl myristate, glycerin, glyceryl stearate, propylene glycol, PEG-100 stearate, polyacrylamide, cetyl alcohol, avena sativa kernel extract, fragrance, DMDM hydantoin, stearyl alcohol, c13-14 isoparaffin, laureth-7, disodium EDTA, menthol, aloe barbadensis leaf juice, methylparaben, propylparaben.
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INGREDIENTS AND APPEARANCE
XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN
dimethicone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58503-038 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 5 mg in 354 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MINERAL OIL (UNII: T5L8T28FGP) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PEG-100 STEARATE (UNII: YD01N1999R) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) CETYL ALCOHOL (UNII: 936JST6JCN) OAT (UNII: Z6J799EAJK) DMDM HYDANTOIN (UNII: BYR0546TOW) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) EDETATE DISODIUM (UNII: 7FLD91C86K) MENTHOL (UNII: L7T10EIP3A) ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58503-038-01 354 mg in 1 BOTTLE; Type 0: Not a Combination Product 11/26/2013 2 NDC:58503-038-02 227 mg in 1 BOTTLE; Type 0: Not a Combination Product 11/26/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 11/26/2013 Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434) Establishment Name Address ID/FEI Business Operations China Ningbo Shangge Cosmetic Technology Corp. 529287434 manufacture(58503-038)
