Pacific Gel: Package Insert and Label Information

PACIFIC GEL- alcohol gel
Ad Medios & Mkt, S.A. de C.V.

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.

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

polyacrylic acid (Carbomer), triethanolamine (Trolamine), water

60 ML
(click image for full-size original)

250 ML
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500 ML
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1000 ml
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3785 ml
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20 L
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200 L
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5000 ml NDC: 79058-002-06

PACIFIC GEL
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:79058-002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
TROLAMINE 1 mL in 100 mL
POLYACRYLIC ACID (8000 MW) 0.03 mL in 100 mL
WATER 28.97 mL in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:79058-002-01 60 mL in 1 BOTTLE None
2 NDC:79058-002-02 250 mL in 1 BOTTLE None
3 NDC:79058-002-03 500 mL in 1 BOTTLE None
4 NDC:79058-002-04 1000 mL in 1 BOTTLE None
5 NDC:79058-002-05 3785 mL in 1 BOTTLE None
6 NDC:79058-002-06 5000 mL in 1 BOTTLE None
7 NDC:79058-002-07 20000 mL in 1 BOTTLE None
8 NDC:79058-002-08 200000 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 06/18/2020
Labeler — Ad Medios & Mkt, S.A. de C.V. (812886810)
Registrant — Ad Medios & Mkt, S.A. de C.V. (812886810)
Establishment
Name Address ID/FEI Operations
Ad Medios & Mkt, S.A. de C.V. 812886810 manufacture (79058-002), label (79058-002)

Revised: 06/2020 Ad Medios & Mkt, S.A. de C.V.

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