Label: SKIN AND SCALP BODY- coal tar lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 59151-646-04 - Packager: Albra Dewyn LLC
- 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 October 11, 2016
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Warnings
For external use only:
Ask a doctor before use if your body has a condition that which convers a large part of the body. Keep out of reach of children. when using this product: do not use for a prolonged period of time without consulting a doctor. Do not use with other forms of psoriasis therapy such as ultrviolet radiation or prescription drugs unless directed by a doctor. Avoid contact with eyes. if contact occurs, rinse eys thoroughly with water. Use cation in exposing skin to sunlght after applying this product. It may increase your tendecy to sunburn for up to 24 hours after application. Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed. If swallowed, get medical help or contact a Poison Control Center right away.
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Inactive Ingredients
Purified water, glycerin (from coconut oil), stearic acid (from coconut oil), pure plant oil complex (soy & jojoba oils), cetylpalmitate (from palm oil), eucalyptus oil, cetearyl alcohol (from palm oil), poly sorbate (from palm oil), glyceryl stearate (from vegetable sources), cetyl alcohol (from palm oil), aminodimethicone (from silica), phenoxyethanol and ethylhexylglycerin (preservative complex from plant source), camphor, menthol, methylparaben, benzoic acid, propylparaben, PEG 150 distearate, vitamin E acetate (DL-alpha-tocopheryl acetate), vitamin A palmitate (Retinyl Palmitate), vitamin H (biotin), polysorbate 80, citric acid.
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INGREDIENTS AND APPEARANCE
SKIN AND SCALP BODY
coal tar lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59151-646 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) BIOTIN (UNII: 6SO6U10H04) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PROPYLPARABEN (UNII: Z8IX2SC1OH) PHENOXYETHANOL (UNII: HIE492ZZ3T) MENTHOL (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) BENZOIC ACID (UNII: 8SKN0B0MIM) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) GLYCERIN (UNII: PDC6A3C0OX) SOYBEAN OIL (UNII: 241ATL177A) CETYL PALMITATE (UNII: 5ZA2S6B08X) EUCALYPTUS OIL (UNII: 2R04ONI662) CETYL ALCOHOL (UNII: 936JST6JCN) AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7) STEARIC ACID (UNII: 4ELV7Z65AP) JOJOBA OIL (UNII: 724GKU717M) POLYSORBATE 80 (UNII: 6OZP39ZG8H) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59151-646-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/03/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 10/03/2016 Labeler - Albra Dewyn LLC (069451336) Establishment Name Address ID/FEI Business Operations Albra Dewyn LLC 069451336 manufacture(59151-646)
