Skin Care: Package Insert and Label Information

SKIN CARE- jojoba oil, chamomile, aloe and tea tree oil soap
Golden B America, LLC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Active ingredients

Jojoba oil (0.9%)

Chamomile Extract (0.9%)

Tea tree oil (0.7%)

Aloe Extract (0.7%)

Purpose

Skin protectant

Anti- itchy

Anti-bacterial

Humectant

Uses

Moisturizes skin and helps to relieve skin irritation and itching for sensitive skin.

Warnings

For external use only

Do not use when skin is red, inflamed, irritated, or painful

When using this product

  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
  • do not apply directly to wound or open cut

Stop use and ask a doctor if

  • rash or irritation on skin develops and lasts
  • condition does not improve or worsen after regular use of this product as directed

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

1. Wet soap to generate foam to cover desired part of face or body

2. Massage foam well into the skin rubbing gently.

3. Rinse after 3-5 min.

4. Pat dry with soft cloth, leaving bit of moisture.

5. Repeat 2-3 times daily as needed.

Inactive ingredients

Sekken Soji, Alkoxy Glycerol, Grape Seed Oil, Tocophenol, Charcoal, Pure Water

Skin Care Soap

skin care soap
(click image for full-size original)

SKIN CARE
jojoba oil, chamomile extract, tea tree oil, aloe extract soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72100-103
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
JOJOBA OIL (JOJOBA OIL) JOJOBA OIL 0.9 g in 100 g
CHAMOMILE (CHAMOMILE) CHAMOMILE 0.9 g in 100 g
ALOE (ALOE) ALOE 0.7 g in 100 g
TEA TREE OIL (TEA TREE OIL) TEA TREE OIL 0.7 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
GRAPE SEED OIL
TOCOPHEROL
ACTIVATED CHARCOAL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72100-103-02 1 CELLO PACK in 1 PACKAGE contains a CELLO PACK (72100-103-01)
1 NDC:72100-103-01 100 g in 1 CELLO PACK This package is contained within the PACKAGE (72100-103-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/13/2018
Labeler — Golden B America, LLC. (081015296)
Registrant — Golden B America, LLC. (081015296)
Establishment
Name Address ID/FEI Operations
Golden B America, LLC. 081015296 relabel (72100-103)
Establishment
Name Address ID/FEI Operations
Asan C&S 631139649 manufacture (72100-103)

Revised: 03/2018 Golden B America, LLC.

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