Label: AOGEL HAND SANITIZER KIDS- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 54312-270-01 - Packager: Compania Internacional de Comercio, S.A. de C.V.
- 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 October 14, 2010
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Drug Facts
Active Ingredient Alcohol Denat. 70%
Uses *Hand sanitizer to reduce bacteria in the skin that potentially can cause disease * Recommended for repeated use.
Warnings
Flamable, keep away from fire or flame
For external use only
Do not use in the eyes. In case of accidental contact with eyes, flush eyes with water. Consult a doctor.
Discontinue use if irritation and redness develop. If condition persists for more then 72 hours, consult a doctor.
Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
*Place a small amount of the product in one hand, and rub hands together until dry * No need to wash or rinse your hands or use towels * Supervise children under 6 years of age when using this product
Other Information
* Do not store above 110 F (43 C) * May discolor some fabrics, or may harm some wood finishes and plastics.
- AO Gel Hand Sanitizer Kids
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INGREDIENTS AND APPEARANCE
AOGEL HAND SANITIZER KIDS
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54312-270 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) LANOLIN (UNII: 7EV65EAW6H) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54312-270-01 60 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 10/14/2010 Labeler - Compania Internacional de Comercio, S.A. de C.V. (822165213) Establishment Name Address ID/FEI Business Operations Compania Internacional de Comercio, S.A. de C.V. 822165213 manufacture
