Label: U.S COLOURS- alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 74655-555-02, 74655-555-03, 74655-555-10 - Packager: East-B Corp.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 May 22, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient(s)
- Purpose
- Use(s)
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Warnings
For external use only. Flammable. Keep away from heat or flame.
Do not use
▪ in children less than 2 months of age
▪ on open skin wounds
When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
- Directions
- Other information
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
U.S COLOURS
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74655-555 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 72 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) PANTHENOL (UNII: WV9CM0O67Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74655-555-10 310 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/15/2020 2 NDC:74655-555-02 70 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/15/2020 3 NDC:74655-555-03 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/22/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/15/2020 Labeler - East-B Corp. (066354219)